Houston-area HIV/AIDS Clinical Trials Directory

The Center for AIDS Information & Advocacy

Last Updated: October 2007

The CFA 1407 Hawthorne Houston, TX 77006 713.527.8219 www.centerforaids.org

Sponsored By

and

Community Advisory Board for the SMART Study (Houston-area Research Team)

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Purpose of the Directory This directory is designed to be a tool for the Houston-area HIV/AIDS community. The information contained within this directory provides details on clinical trials being conducted in the Houston area, though some trials may have additional research sites in other cities. In the spirit of science, The Center for AIDS encourages all individuals to participate in clinical trials for which they may be eligible. However, safety is our first concern. We strongly urge all individuals interested in participating in any clinical trial, including those listed in this directory, to first consult with their primary health care provider. When seeing your health care provider, bring information about the trial that explains what you will need to do as a participant. Ask your health care provider if the clinical trial could negatively affect your health and if he or she thinks it is a good idea for you to participate. Please also review the “What is a Clinical Trial?” section of this directory for general information on clinical trials.

Resources

ACRIA’s TrialSearch http://www.acria.org/clinical_trials ClinicalTrials.gov http://www.clinicaltrials.gov Office for Research Protection http://www.hhs.gov/ohrp/ WomenCanDo.org http://www.womancando.org/ Office of Research on Women’s Health http://orwh.od.nih.gov/inclusion.html

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Table of Contents

Page I. “What is a clinical trial”

A. Definition of Phases ........................................................................ 4 B. Clinical Trial Phases........................................................................ 4 C. Inclusion/Exclusion Criteria ............................................................. 5 D. Institutional Review Board............................................................... 5 E. Informed Consent............................................................................ 6 F. Potential Benefits of Participating ................................................... 6 G. Potential Liabilities of Participating ................................................. 6 H. You Should Also Know.................................................................... 7

II. Listings by Category

A. Antiretroviral Treatment – New Therapies........................................ 8 B. Antiretroviral Treatment – Not Working or Intolerance .................... 12 C. Behavior and HIV ............................................................................ 14 D. Children........................................................................................... 16 E. Co-conditions/Opportunistic Infections............................................ 20 F. Fat Metabolism/Lipodystrophy ........................................................ 23 G. Miscellaneous ................................................................................. 24 H. Naïve or New to HIV Treatment ...................................................... 26 I. Pregnant Women ............................................................................ 27

III. Listings by Major Institution

Baylor College of Medicine..................................... 16-19, 20, 23, 26 Ben Taub General Hospital ........................................................... 21 Bering Omega Dental Clinic .......................................................... 21 Gulf States Hemophilia & Thrombophilia Center........................... 25 Infectious Disease Associates of Houston .................................... 12 Legacy Community Health Services ............................................. 23 Texas Children’s Hospital................................................... 16-19, 26 Therapeutic Concepts/Donald R. Watkins...................8-9, 12-13, 25 Thomas Street Clinic .................................................... 14, 21-22, 24 University of Texas Galveston.................................................... 9-10 University of Texas Houston ......................... 8-11, 13-15, 22, 24, 25 University of Texas MD Anderson Cancer Center......................... 14 VA Medical Center ...................................................... 11, 13, 20, 24

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What is a “Clinical Trial?” DEFINITION A clinical trial is a research study that allows scientists and doctors to better understand the effects of an intervention (for example, a medication or surgical procedure). In the case of medications, clinical trials are necessary to gain approval by the US Food and Drug Administration (FDA). A clinical trial may be used to examine any of the following:

• Whether an experimental medication works in people • Which of two clinical approaches works best • How a medication makes people feel • Whether a surgery or procedure works

CLINICAL TRIAL PHASES Clinical trials are divided into phases: Preclinical, 1, 2, 3, and 4. These trials are often used to study potential prescription medications, including HIV medications, before their actual approval. These phases are designed to examine different aspects of a treatment or therapy. The following explains what questions each phase of a trial is designed to answer: Preclinical – How well does the treatment work (for example, in fighting HIV) in the

test tube? Does it work and is it safe in animals? Phase 1 – Is the treatment safe for people? Phase 2 – Does the treatment do what it is supposed to do in people? Phase 3 – How does the treatment work after a long period of time in people or how

does the treatment compare to the current treatment used for this condition (standard of care)?

Phase 4 – Now that the FDA has approved this treatment, is it still working well in people? Also, are there any unanswered questions about this treatment (such as, can pregnant women use this medication or are there long-term side effects)?

For more advanced studies (Phase 2 through 4), participants in clinical trials may be assigned to one of two groups. The first group is called the “treatment” group and the second is called the “control” group. The participants in the “treatment” group do receive the treatment, while the “control” group participants do not receive the

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treatment. In some studies, the “treatment” group receives the “study” treatment, while the control group receives the “standard of care” treatment. If you participate in a clinical trial, you should not have to participate in all phases of the trial. Your role as a participant should be completely explained in the “informed consent form” (see below). INCLUSION AND EXCLUSION CRITERIA Clinical trials require participants to have certain characteristics AND to not have certain characteristics. These characteristics are different for each clinical trial. “Inclusion Criteria” are the characteristics an individual MUST HAVE to be considered for participation in a clinical trial. For example, with a medication to treat HIV, the study participants must have HIV, or perhaps have more than a certain number of T-cells. “Exclusion Criteria” are characteristics an individual CANNOT HAVE to be considered for participation in a clinical trial. For example, with a new medication, pregnant women cannot participate if the risk of birth defects from the new drug is unknown. In this directory, it is not possible to list all inclusion and exclusion criteria for each trial (some are quite lengthy). If you are interested in participating in a clinical trial, always check with the principal investigator (PI), the research coordinator, or the “contact” person about the specific inclusion and exclusion criteria for that trial.

INSTITUTIONAL REVIEW BOARD (IRBs) An Institutional Review Board is a group of individuals whose purpose is to protect the rights of people participating in clinical trials. IRBs were created by the National Research Act (1974) in response to the Tuskegee Syphilis Study (1932–1972), a study in which patients were treated unethically. The principal investigator (PI) of a clinical trial is responsible for meeting the IRB’s requirements for the use of human and animal subjects in their research before the trial begins, during the trial, and after the trial is over. For more information on IRBs, visit the website of the US Government Office for Research Protection (Department of Health and Human Services) at http://www.hhs.gov/ohrp/.

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INFORMED CONSENT When signing up to participate in a clinical trial, a person is presented with an informed consent form. Those patients under 18 years of age must receive their parent or guardian’s signature on this form to participate in a clinical trial. The informed consent form should be written in plain language that is easy to understand and should include the following information:

• Complete information about the clinical trial, including the purpose of the study, tests that you will undergo while participating, the medications you will take while participating, your rights as a participant, and the advantages and disadvantages of participating in this study.

• Contact information for the IRB responsible for the study AND the clinical trial’s PI.

ALSO…

• BEFORE signing the form, participants need to fully understand their role in the clinical trial. The participant may also receive a verbal explanation of the form and the clinical trial. Any questions a participant has should be answered by the PI or research coordinator.

• Participants should receive a copy of the form to take home with them, as well as a copy of any updates of the original consent form. These updates could include changes in how the study is being done or how the study information is being used.

POTENTIAL BENEFITS (PROS) FOR PARTICIPATING Some potential benefits (PROS) to participating in a clinical trial include:

• Access to new medications not approved by the FDA • A better relationship with health care providers (in other words, more time spent

discussing your health with doctors) • A good feeling that comes from helping others. The medical community will

gather information from you that will be passed on to the community at-large. This could help improve the lives of others by offering new or better treatments for illnesses like HIV/AIDS, cancer, hepatitis, etc.

POTENTIAL LIABILITIES (CONS) FOR PARTICIPATING Some potential liabilities (CONS) to participating in a clinical trial include:

• Safety and health concerns (for example, side effects of the new medication or the drugs used in the trial interfering with your current medical regimen)

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• Uncomfortable procedures (for example, blood draws or staying overnight at a hospital/facility)

• Financial considerations (for example, time off from work or any out-of-pocket costs for expenses that the clinical trial does not cover).

YOU SHOULD ALSO KNOW When participating in a clinical trial, keep in mind the following things:

• You should be given an informed consent form that explains the clinical trial. This form should be verbally explained to you in language that you can understand.

• Participation in any clinical trial is always voluntary. No one can make you take part if you do not want to.

• You can drop out of the trial ANY TIME THAT YOU WISH.

• You should see your regular doctor as scheduled.

• You do not have to notify your employer but procedures in some clinical trials may require time away from work (for example, lab work or doctor visits). When the trial is completed, you should be told the study results.

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Antiretroviral Treatment – New Therapies

GRACE (Gender, Race and Clinical Experience) TMC114 HIV 3004: A Study to Determine the Effectiveness, Safety, and Tolerability of Prezista by Gender and Race when Administered with Other Antiretroviral Medications in HIV-positive Women and Men Contact: Kenneth Degazon Phone: 713-526-9821 Address: Therapeutic Concepts PA

4900 Fannin Street; Houston, TX 77004 Email: research@josephgathe.com This trial aims to study the safety and effectiveness of darunivir (Prezista) plus ritonavir (Norvir) in HIV-positive women and men, as well as in people of different races. This study will enroll 70% women and will compare how well darunivir is tolerated in women compared to men; it will also compare how well the drug works in people of different races. Individuals will be given darunivir in combination with an optimized background regimen (standard of care treatment for HIV) over a 48-week treatment period. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) have documented HIV-1 infection, (2) be age 18 or older, (3) have a viral load greater than or equal to 1000, and (4) be on an HIV treatment regimen that includes a protease inhibitor (PI) and/or a nucleoside reverse transcriptase inhibitor (NRTI) for at least 12 weeks. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Victor E4: A Study to Determine if Vicriviroc (experimental HIV medication) Can Lower HIV-1 Viral Load when Taken with Optimized Background Therapy (OBT) Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu This study will compare an HIV regimen including OBT plus vicriviroc with an HIV OBT regimen without vicriviroc. OBT will be determined by the research clinician based on a participant’s previous HIV medication use, resistance tests (genotype/phenotype), and the HIV medication’s toxicity. OBT must include a protease inhibitor (PI) plus ritonavir, an active drug that the participant is not resistant to based on resistance testing. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) have a viral load greater than 1000 copies, (2) currently be using HIV medications, and (3) not have cancer or a history of cancer. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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SETTLE Study: Switching Epzicom to Truvada for Lipid Evaluation Contact: Benjamin Daquioag, Jr. Phone: 713-526-9821 Address: Therapeutic Concepts PA

4900 Fannin Street; Houston, TX 77004 Email: research@josephgathe.com The purpose of this study is to understand the change in the amount of lipids found in the blood of people who have a low viral load and who switch from Epzicom (abacavir/ lamivudine) to Truvada (emtricitabine/tenofovir). People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be 18 years of age or older, (2) have a viral load less than 400 on their current HIV medication regimen, and (3) be on an HIV medication regimen that contains Epzicom given one time a day for 12 weeks or more. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Abbott M06-802 (experimental HIV medication): A Phase 3, Randomized, Open-label Study of Lopinavir/Ritonavir Tablets Once Daily versus Twice Daily when Co-administered with NRTI in Antiretroviral-experienced HIV-1 Infected Participants Contact: Kenneth Degazon Phone: 713-526-9821 Address: Therapeutic Concepts PA

4900 Fannin; Street Houston, TX 77004 Email: research@josephgathe.com Contact: Cheryl Mogridge, RN Phone: 409-747-0214 or 1-877-324-2288 Address: University of Texas Medical Branch Galveston (ACTU)

301 University Boulevard; Galveston, TX 77555-0435 Email: clmogrid@utmb.edu Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine

Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu This study aims to compare whether lopinavir/ritonavir (Kaletra) once a day is safer and easier to tolerate than taking it twice a day. The study will also look at whether a once-a-day dose is more helpful at lowering viral load than a twice-a-day dose. Participants will continue their current HIV regimen while participating in this trial. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be at least 18 years of age, (2) have never received Kaltera, (3) not currently be breastfeeding, and (4) be failing their current HIV regimen. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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A Phase II Dose-escalating, Placebo-controlled, Double-blind, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 (experimental HIV medication) Administered as Functional Monotherapy for 14 days in Addition to Current HAART Therapy Contact: Gerianne Casey Phone: 409-747-0214 or 877-324-2288 Address: University of Texas Medical Branch Galveston (ACTU) 301 University Boulevard; Galveston, TX 77555-0435 Email: gecasey@utmb.edu PA 103001 is an experimental HIV medication that is part of a new class of HIV drugs called “maturation inhibitors” that work at a late stage in the HIV life cycle. PA 103001 is a version of another experimental HIV maturation inhibitor called Bevirimat (PA-457). Researchers want to learn how safe the medication is in people and how well it controls HIV reproduction. Current HIV treatment guidelines recommend combination therapy with agents from at least 2 classes of HIV medications. The guidelines do not recommend monotherapy. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) have a T-cell count greater than 200, (2) not have any opportunistic infections (i.e., PCP, toxoplasmosis, thrush), and (3) be resistant to at least one class (non-nucleoside reverse transcriptase inhibitors [NNRTI], nucleoside reverse transcriptase inhibitors [NRTI], protease inhibitors [PI], or entry inhibitors) of HIV medications. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

TMC114 C229: A Randomized, Open-label Trial to Compare the Effectiveness, Safety and Tolerability of Darunivir (Prezista) plus Ritonavir (Norvir) Given One Time Each Day to Darunivir plus Ritonavir Given Two Times Each Day in Newly Treatment-experienced HIV-1 Infected People Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu This study will compare a once-a-day combination of 800 mg of darunivir (Prezista) plus 100 mg ritonavir (Norvir) to a twice-a-day combination of 600 mg darunivir plus 100 mg ritonavir. The researchers will examine how well the combinations stop HIV from reproducing, how safe the combinations are in the body, and how well participants tolerate the medication. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) be on a stable HAART regimen for 12 weeks when starting the study, (2) have a viral load greater than 1000, and (3) not have HIV mutations that are resistant to darunivir. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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PRO140-2401 (experimental HIV medication): A Phase 2 Randomized, Double-blind Study of PRO 140 Given Either by Injection into the Fat (Subcutaneous Administration) or by IV (Intravenous Administration) into the Vein Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine

Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu The purpose of this study is to determine how well PRO 140 controls HIV, how safe the medication is for humans, and how the medication works in the body. Researchers also want to know if the medication works better in the body if it is injected just below the skin (subcutaneous) or if it is injected into a person’s vein (intravenous). Information from this clinical trial will be used to determine other clinical trials that should be done on PRO 140. People interested in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) have a T-cell count of approximately 200, (2) not have ever had a T-cell count less than 200, and (3) not have taken any antiretrovirals within 12 weeks of the screening visit. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. STALWART: Study of Aldesleukin (experimental HIV medication) with and without Antiretroviral Therapy Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine

Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu Contact: Eusebia Calvillo-Stevens Phone: 713-794-7278 Address: Michael E. Debakey VA Medical Center; (111-G)

2002 Holcombe Boulevard; Houston, TX 77030 Email: Eusebia.calvillo-stevens@va.gov This study will investigate a type of interleukin-2 called aldesleukin, an experimental medication. Interleukin-2 assists the body in making T-cells. The study will determine if interleukin-2 lowers HIV viral load better when given by itself or when it is given in combination with other HIV medications. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) have a T-cell count that is greater than or equal to 300, (2) be able to begin taking an HIV treatment that includes 1 protease inhibitor (PI) and 2 non-nucleoside reverse transcriptase inhibitors (NNRTIs), (3) not have used interleukin-2 before, and (4) not have used corticosteroids or received chemotherapy or experimental cytotoxic (toxic to cells) drugs within 45 days before starting this study. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Antiretroviral Treatment – Not Working or Intolerance

Early Access of MK-0158 (experimental HIV medication) in combination with an Optimized Background Antiretroviral Therapy in Highly Experienced HIV-1 Infected Patients with Limited to No treatment Options Contact: Kenneth Degazon Phone: 713-526-9821 Address: Therapeutic Concepts PA

4900 Fannin Street; Houston, TX 77004 Email: research@josephgathe.com The purpose of this study is to give early access (i.e., access to the drug before it is approved by the FDA) to MK-0158 to HIV-positive people with limited treatment options (“salvage therapy patients”). People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) not be pregnant, (2) be 16 years old or older, and (3) be on an HIV regimen that is not working well to control the virus. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. AI424128: A Phase 4 Study to Evaluate the 150L Viral Mutation in Patients Experiencing Virologic Failure on a Regimen Containing Atazanavir (Reyataz) Contact: Victor Feinstein, MD Phone: 713-799-9997 Address: Infectious Disease Associates of Houston 6560 Fannin Street; Houston, Texas 77030

This study seeks to examine genetic changes in HIV that prevent the antiretroviral drug atazanavir (Reyataz) from working properly. This study requires clinic visits by study participants. Participants may be asked to have their blood drawn twice. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be on an antiretroviral regimen containing atazanavir, (2) have a viral load of 1,000 copies or more after 24 weeks of therapy, and (3) have a viral load rebound to more than 1,000 copies after achieving a viral load of less than 400 copies on at least two consecutive measurements. Individuals who are selected to participate in this study will be compensated for their travel expenses. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Koronis KP 1461 (experimental HIV medication): Open-label Study to Evaluate the Safety, Efficacy, and Tolerability of KP1461 as Monotherapy in Treatment-experienced HIV Patients Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine

Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu KP 1461 works by forcing HIV to make many copies of itself in a short timeframe. By making so many copies of itself, HIV gets worn down and can no longer reproduce. This study will examine KP 1461 in participants to see if it will stop drug resistance from occurring in people taking HIV medication therapy. Participants will only be able to take KP 1461 during this time. Current HIV treatment guidelines recommend combination therapy with agents from at least 2 classes of HIV medications. The guidelines do not recommend monotherapy. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be HIV-1 positive and (2) have been on HIV treatment therapy. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. TMC 125-C214 (experimental HIV medication): Early Access of TMC 125 in Combination with Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects with Limited Treatment Options Contact: Kenneth Degazon Phone: 713-526-9821 Address: Therapeutic Concepts PA

4900 Fannin Street; Houston, TX 77004 Email: research@josephgathe.com Contact: Eusebia Calvillo-Stevens Phone: 713-794-7278 Address: Michael E. Debakey VA Medical Center (111-G)

2002 Holcombe Boulevard; Houston, TX 77030 Email: Eusebia.calvillo-stevens@va.gov The purpose of this study is to give early access (i.e., access to the drug before it is approved by the FDA) to TMC 125 to people that are treatment-experienced and who have failed several antiretroviral regimens. These individuals have limited treatment options (i.e., “salvage therapy patients”). People interested in participating in this study must meet several inclusion/ exclusion criteria including: (1) be 18 years of age or older, (2) have limited treatment options due to failure of several antiretroviral regimens, (3) have been on 2 different protease inhibitor (PI) regimens, and (4) be unable to use FDA approved non-nucleoside reverse transcriptase inhibitors (NNRTIs) due to being resistant. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Behavior and HIV

An Innovative Telephone Intervention for HIV-Positive Smokers Contact: Netri Mehta Phone: 713-745-4479 Address: Thomas Street Clinic/University of Texas MD Anderson Cancer

Center, Dept. of Behavioral Science Unit 1330; P.O. Box 301439; Houston, TX 77230-1439

Email: nmehta@mdanderson.org The goal of this study is to assess a smoking cessation intervention targeted to an HIV/AIDS patient population. Within this group, between 50 to 70% of individuals smoke. New antiretroviral regimens are increasing the life span of HIV-positive individuals so they are now more vulnerable to both the long- and short-term impact of cigarette smoking. Smoking is a significant factor in the course, management, and quality of life for patients with HIV/AIDS. Despite this, there are no published studies exploring the effectiveness of a smoking cessation intervention for HIV-positive smokers who are interested in quitting smoking. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) be 18 years of age or older, (2) be a current, regular smoker (more than 5 cigarettes per day for the past 30 days), and (3) be willing to set a quit date within 1 week of baseline assessment. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria, as well as other areas to be explored by the study. A Transtheoretical Model (behavior change process) Group Therapy for Cocaine Users Contact: Angela L. Stotts, PhD Phone: 713-500-7590 Address: University of Texas Houston Medical Sciences Institute

Rm JJL-324; 6431 Fannin Street; Houston, TX 77030 Email: angela.l.stotts@uth.tmc.edu The purpose of this study is to examine how well a group therapy program for cocaine abuse works. This program is based on a behavior change process called the transtheoretical model of change. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) not have a mental health problem other than cocaine addiction, (2) be willing to participate in a 6 week program, and (3) not have any substance abuse withdrawal symptoms that require a physician. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria, as well as other areas to be explored by the study.

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Acceptance Therapy (behavioral change process) During Methadone Detoxification Contact: Ann Garcia Phone: 713-500-2804 Address: University of Texas Houston Medical Sciences Institute

Rm MSI-115A; 1300 Moursund; Houston, TX 77030 Email: ann.d.garcia@uth.tmc.edu The aim of this study is to develop a detox program for people addicted to opiates (e.g., cocaine, heroin, opium). The purpose of this trial is to determine if Acceptance and Commitment Therapy, a type of behavioral change process, is successful at helping people stop taking opiates. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) be between 25 and 55 years of age, (2) use heroin or methadone for the last 5 years, and (3) not have severe mental problems that require the treatment of a physician. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria, as well as other areas to be explored by the study.

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Children

Sleep, HIV Disease Progression, and Function in HIV-infected Children and Adolescents Contact: Chivon McMullen-Jackson Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital

6621 Fannin Street; Houston, TX 77030 Email: cdmcmull@texaschildrenshospital.org The purpose of this study is to explore how HIV affects sleep in HIV-positive children. Specifically, the study will examine changes in sleep-regulating cytokines (components of the immune system) and cytokines that fight HIV disease in children. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be 8 to 17 years old, (2) be HIV-positive, and (3) not be pregnant. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria. PHACS: A Study Monitoring Antiretroviral Toxicities in HIV-uninfected Children Born to HIV-infected Women (SMARTT) Contact: Norma Cooper, RN, Study Coordinator Phone: 832-824-1319 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: njcooper@texaschildrenshospital.org This study will follow two groups of HIV-negative children that have been exposed to both HIV and HIV antiretrovirals. Both groups will be examined to determine the consequences of developing health-related conditions that may be related to exposure to HIV medications while they were in their mother’s womb or during the first 2 months of their life. Clinicians will examine several aspects of the children’s health, including cardiac and neurological function, metabolism, growth, behavior, language skills, and hearing. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be less than 12 years of age at enrollment and (2) have been exposed to HIV but be HIV negative. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria.

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PHACS: Adolescent Master Protocol (AMP) Contact: Norma Cooper, RN, Study Coordinator Phone: 832-824-1319 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: njcooper@texaschildrenshospital.org The AMP study will examine how HIV infection and exposure to HIV medications perinatally (i.e., exposed from 5 months before birth to 1 month after birth) affect the health of pre-adolescents and adolescents. Clinicians will examine how a child’s growth, sexual maturity, bones, heart, and nervous system have been affected by HIV and HIV medications. This study will enroll children between the ages of 7 years and 16 years of age. The first group will consist of 600 children who were exposed to HIV perinatally and are HIV infected. This group will be compared to a second group of 200 perinatally exposed children who are not HIV infected. The two groups of children will be from similar social and economic backgrounds and similar age groups. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria. P1065: Phase 1/2 Study of the Safety and Immunogenicity (ability to make the immune system respond) of MCV-4 (a vaccine for meningitis) in HIV-positive Youth Contact: Chivon McMullen-Jackson, RN, Study Coordinator Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: cdmcmull@texaschildrenshospital.org Bacterial meningitis infection is common in youth age 11 to 25 years old in the United States. This disease can be treated with antibiotics but death rates for meningitis are up to 53%. Clinicians think vaccination against meningitis may help prevent the disease in HIV-positive youth. The purpose of this study is to examine the safety of MCV-4, a meningitis vaccine, and to determine how well MCV-4 causes the immune system to respond. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) be HIV-positive, (2) be on a stable HIV medication therapy for at least 90 days, (3) be willing to complete all of the study vaccinations and evaluations, and (4) have a parent/guardian willing to provide informed consent, if applicable. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria.

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P1066: A Phase I/II Study of the IMPAACT Group to Examine How Raltegravir (Isentress), a new HIV medication, Works in Children and Adolescents Contact: Chivon McMullen-Jackson, RN, Study Coordinator Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: cdmcmull@texaschildrenshospital.org The purpose of this study is to examine the safety and effectiveness of raltegravir (Isentress), a new HIV medication, in treatment-experienced HIV-positive children and adolescents. Raltegravir is a new class of HIV medication called an integrase inhibitor. Integrase is a protein that HIV uses to reproduce in the human body. Raltegravir prevents integrase from working properly. This drug has been tested for safety and effectiveness in adults but not in children. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be HIV-positive, (2) be on a controlled HIV medication regimen for at least 12 weeks before starting the study, (3) have a viral load of 1,000 copies or more, and (4) have a parent/legal guardian willing to provide informed consent. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria. ATN 024: A Randomized Trial of Three Hepatitis B Vaccinations in HIV-Positive Youth Contact: Chivon McMullen-Jackson, RN, Study Coordinator Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: cdmcmull@texaschildrenshospital.org Hepatitis B is a contagious virus that can damage a person's liver. Hepatitis B virus can be prevented by vaccination. However, the vaccine does not protect many HIV-positive people against the Hepatitis B virus. This clinical trial will attempt to improve HIV-positive people’s response to Hepatitis B vaccination. This trial will compare immune system response of HIV-positive children to three Hepatitis B vaccination regimens. People interested in this study must meet extensive inclusion/exclusion criteria including: (1) be 12 to 24 years in age, (2) never have been given a Hepatitis B vaccination or have had only 1 Hepatitis B vaccination, (3) not be pregnant, and (4) be willing to use an approved method of birth control during the study. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria.

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Longitudinal (Long-term) Epidemiological Study to Gain Information on HIV/AIDS in Children and Youth Contact: Amy Leonard, Research Coordinator Phone: 832-824-1319 Address: Baylor College of Medicine/Texas Children's Hospital 6621 Fannin Street; Houston, Texas 77030 Email: adleonar@texaschildrenshospital.org This study was designed to collect data on HIV disease progression in HIV positive children and adolescents. Clinicians hope to improve the health of HIV-positive children and adolescents, and to enhance the research used for prevention activities for HIV-positive adolescents. People interested in participating in this study must meet several exclusion/inclusion criteria including: (1) be receiving HIV medical treatment from a LEGACY-funded pediatric or adolescent clinic, (2) be HIV-positive from birth to 24 years of age, and (3) speak English, Spanish, French or Creole. Interested individuals or legal guardians of minors should speak with the study contact person for complete inclusion and exclusion criteria.

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Co-conditions/Opportunistic Infections

Evaluation of Immune Response Induced by Immunization of HIV-infected Subjects with Pneumococcal Vaccine Contact: Maria Rodriguez-Barradas, MD Phone: 713-794-8856 Address: Michael E. Debakey VA Medical Center; (111-G)

2002 Holcombe Boulevard; Houston, TX 77030 Email: maria.rodriguez-barradas2@med.va.gov This study aims to evaluate how well pneumococcal (pneumonia) vaccine works in HIV-positive people. Researchers will examine the vaccine in HIV-positive people in 3 different ways. First, the study will compare people with T-cell counts less than 200 and who have also been on antiretroviral therapy for at least 6 months before taking the pneumococcal vaccine to people who took the vaccine before starting antiretroviral therapy. Second, the study will examine what happens to participants if they are vaccinated a second time with the pnemococcal vaccine. Finally, the study will compare how effective 7-valent pnuemococcal conjugate vaccine (type of vaccine used to prevent pneumonia) is to the effectiveness of polysaccharide vaccine (another type of vaccine used to prevent pneumonia). Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Longitudinal Study of Ocular (eye) Complications of AIDS (LSOCA) Contact: Steve S. Spencer, COMT Phone: 713-798-5969 Address: Baylor College of Medicine 1 Baylor Plaza, NC 206; Houston, TX 77030 Email: sspencer@bcm.tmc.edu This observational study aims to provide information on the number of new cases and development of eye complications in people with AIDS. The study will: (1) examine how cytomegalovirus (CMV) retinitis and other ocular complications develop in HIV-positive people, (2) determine the effect of highly active antiretroviral therapy (HAART)-induced changes in immune status on the risk of CMV retinitis and other eye complications of AIDS, (3) determine which types of patients are at high risk of CMV retinitis and other eye complications of AIDS, and (4) evaluate the effects of treatments of CMV retinitis and other eye complications on visual function, quality of life, and survival. This study will only accept 5 people who have never had an eye complication due to AIDS. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be diagnosed with AIDS according to the Centers for Disease Control definition and (2) have documentation of an opportunistic eye infection due to AIDS in one or both eyes during the last 90 days. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months versus Daily Isoniazid for 9 Months for the Treatment of Latent (Not Active) Tuberculosis (TB) Infection Contact: Ruby Nickson Phone: 713-873-2370 Address: Ben Taub General Hospital

1502 Ben Taub Loop, 6th Floor, Pulmonary Laboratory Houston, TX 77030

Email: rnickson@bcm.tmc.edu Contact: Terry Scott Phone: 713-873-4054 Address: Thomas Street Clinic

2015 Thomas Street; Houston, TX 77009 Email: tscott@bcm.tmc.edu The primary objective of this Phase 3 clinical trial is to compare a regimen of rifapentine (an antibiotic for TB treatment) and isoniazid (another antibiotic for TB treatment) taken weekly for 3 months to a regimen of isoniazid taken daily for 9 months. Researchers want to see which treatment works better. People interested in participating in this study must have had a skin reaction to the TB skin test that indicates they require treatment of latent (not active) infection to prevent TB. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Effectiveness and Safety of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV-positive People Contact: Robert Marroquin Phone: 409-382-5711 Address: Bering Omega Dental Clinic

1427 Hawthorne Street; Houston, TX 77006 Oral candidiasis, or thrush, is a common opportunistic infection that HIV-positive people may experience. The purpose of this study is to examine two treatments to determine which one works best at treating thrush. Individuals will either take one 50 mg Lauriad tablet by mouth or five 14 mg clotrimazole tablets each day. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) have an active thrush infection, (2) not be breastfeeding, and (3) be HIV-positive. Interested individuals should speak to the study contact person for complete inclusion and exclusion criteria.

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Texas Repository for AIDS Neuropathogenesis Research Contact: Terry Scott Phone: 713-873-4054 Address: Thomas Street Clinic

2015 Thomas Street; Houston, TX 77009 Email: tscott@bcm.tmc.edu Contact: Jean Richey Phone: 409-747-9518 Address: University of Texas Medical Branch at Galveston

301 University Boulevard; Galveston, TX 77555-0187 Email: fjrichey@utmb.edu This clinical trial aims to examine the effect of HIV infection on the brain and nervous system. Participants will have tests that examine their nervous system and mental state, and the researchers will look at what medications patients have been using. Participants will also give samples of their blood and urine. These tests will be done every 6 to 12 months. In addition, participants may be asked to give a sample of their cerebral spinal fluid, which would be collected by lumbar puncture (spinal tap). This portion of the testing is optional (that is, it can be refused). However, participants are required (that is, they have to) to have an autopsy and to donate their organs to research if they die while participating in this clinical trial. Compensation is available for time and inconvenience. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) have a T-cell count less than 50 or (2) have a life-threatening condition, such as cancer, heart disease, lung disease, or liver disease. Interested individuals should speak to the study contact person for complete inclusion and exclusion criteria.

Safety Study of Alphanate in Previously Treated Patients with Severe Hemophilia Contact: Madeline Cantini Phone: 713-500-8360 Address: Gulf States Hemophilia & Thrombophilia Center

Suite 400 HMC; 6655 Travis; Houston, TX 77030 Email: madeline.cantini@uth.tmc.edu The purpose of this study is to determine how effective and how safe alphanate (a product made from blood) is in people who have previously used plasma (blood) products made from Factor VIII. People interested in participating in this study must meet several inclusion/exclusion criteria including, but not limited to: (1) not have been treated with Alphanate before, (2) be between the ages of 6 and 65 years old, and (3) be diagnosed with hemophilia A. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria, as well as other areas to be explored by the study.

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Fat Metabolism/Lipodystrophy

The Effects of Leptin Therapy on Fat Metabolism in HIV-positive Individuals Contact: Ashok Balasubramanyam, MD Phone: 713-798-8654 Address: Baylor College of Medicine; Dept. of Medicine; BCM 285/BCMN 700B 1 Baylor Plaza; Houston, TX 77030 Email: ashokb@bcm.tmc.edu People with lipodystrophy have problems with fat metabolism. Leptin is a substance in the body that controls the breakdown of fat. Levels of leptin may be low in some people infected with HIV. This study looks at the effects of leptin treatments given by injection on fat metabolism. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be HIV-positive and (2) have low leptin levels. A 2-hour screening is needed to measure your natural level of leptin. If you qualify and decide to participate, three visits to the Clinical Research Center will be required: one visit before starting leptin therapy, one visit 2 months after starting leptin, and one visit 4 months after starting leptin. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Heart Positive Study Contact: Ivonne Coraza Phone: 713-830-3034 Address: Legacy Community Health Services

3311 Richmond Avenue, Suite 100; Houston, TX 77098 Email: icoraza@legacycommunityhealth.org HIV infection and the HIV medications used to treat the virus can cause increases in an individual’s risk for heart disease. A condition known as lipodystrophy, which results in changes in body fat, high levels of fat in the blood, and high levels of sugar (glucose) in the blood, is sometimes associated with this increased risk. This study aims to examine why this occurs. This study will test the effects of lifestyle changes and FDA-approved medications that are used to treat high levels of cholesterol and triglycerides (fats in the blood). People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be 18 to 65 years of age, (2) be HIV-positive, and (3) have been receiving antiretroviral therapy for at least 6 months. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Miscellaneous Collection of Blood Samples from HIV-infected People Contact: Hilda Cuervo Phone: 713-500-6751 Address: Thomas Street Clinic/University of Texas Houston School of

Medicine; Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu Genetic (present at birth) differences among people with HIV may explain the differences in how fast or slow HIV progresses in people and how different people response to HIV therapy. The purpose of this study is to collect blood samples from HIV-positive people for genetic studies that may take place in the future. Blood samples from this study will be used to help researchers compare human genetic factors with clinical data from other clinical studies. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be currently participating in or have previously participated in a clinical trial and (2) have given informed consent for participation in a clinical trial. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. Veterans Aging Cohort Study (VACS) Contact: Cynthia Rose Phone: 713-794-7482 Address: Michael E. Debakey; VA Medical Center (111-G) 2002 Holcombe Boulevard; Houston, TX 77030 Email: crose@bcm.edu The purpose of this study is to compare the aging process of HIV-positive people to HIV-negative people. The study will examine how HIV affects the aging process. It will also examine how HIV complications that influence aging can be treated. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be HIV-positive and (2) be a US veteran. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Naïve or New to Antiretroviral Treatment

VERVE: A Randomized, Double-blind Trial to Evaluate Nevirapine Extended Release Formula in Comparison with Nevirapine Immediate Release Formula Contact: Hilda Cuervo Phone: 713-500-6751 Address: University of Texas Houston School of Medicine

Houston, TX 77030 Email: hilda.cuervo@uth.tmc.edu Contact: Bernie Miguel Phone: 713-526-9821 ext. 221 Address: Therapeutic Concepts PA

4900 Fannin Street; Houston, TX 77004 Email: research@josephgathe.com This study aims to compare the effects of 400 mg of nevirapine extended release (lasts longer in the body) given one time each day to 200 mg of nevirapine immediate release given two times each day. Researches will examine how effective the medication regimens are at controlling HIV’s levels in the body. Participants will be in the clinical trial for approximately 48 weeks. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) not have taken any HIV medications, (2) have a viral load greater than or equal to 1000, and (3) if male, have a T-cell count between 50 and 400; if female, have a T-cell count between 50 and 250. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.

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Pregnant Women

Pharmacokinetic Study of HIV Medications Taken During Pregnancy Contact: Chivon McMullen-Jackson Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital

6621 Fannin Street; Houston, TX 77030 Email: cdmcmull@texaschildrenshospital.org The purpose of this study is to determine what doses of HIV medications are safe for pregnant women. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be at least 20 weeks (5 months) pregnant, (2) be enrolled in the IMPAACT P1025 clinical trial, (3) not be pregnant with more than one baby, and (4) not be on medications that interfere with the HIV medications being used in the study. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria. IMPAACT: P1025 Perinatal Core Protocol Contact: Chivon McMullen-Jackson Phone: 832-824-1339 Address: Baylor College of Medicine/Texas Children's Hospital

6621 Fannin Street; Houston, TX 77030 Email: cdmcmull@texaschildrenshospital.org The purpose of this study is to collect and study medical information (clinical and laboratory) about pregnant women or mothers who have just given birth as a way to improve the medical treatment of HIV-positive pregnant women and their children. People interested in participating in this study must meet several inclusion/exclusion criteria including: (1) be at least 14 weeks pregnant OR have delivered a live or stillborn infant and are within 14 days of the delivery and (2) not be currently enrolled in study PACTG 367. Interested individuals should speak with the study contact person for complete inclusion and exclusion criteria.