care and prevention in hiv vaccine trials: a site perspective guy de bruyn perinatal hiv research...
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Care and Prevention in HIV Vaccine Trials: a site perspective
Guy de Bruyn
Perinatal HIV Research UnitUniversity of the Witwatersrand
Chris Hani Baragwanath HospitalJohannesburg, South Africa
Access to care (modified from Grady)
• Care which is part of the scientific design
• Care needed to safely complete the trial
• Care for injuries and adverse events
• Post trial access
• Ancillary care– Care that some participants will
predictably need
Dialogue?
• “a comprehensive care package should be agreed upon through a host/community/sponsor dialogue which reaches consensus prior to initiation of a trial” (UNAIDS 2000, #16)…
Protocol mandates
• Avoiding pregnancy during the vaccination period
• Assessing symptoms of illness
• Ensuring adequate standard of care to control participants– Counselling – pre/post-test, risk reduction,
safer sex– Providing condoms
Care needed to safely complete the trial
• Resuscitation equipment
• Laboratory monitoring of haematologic parameters and other clinical laboratory values of potential interest– Anaemia– Leukopaenia– Alteration of hepatic enzyme tests
Ancillary care in HIV Vaccine trials
• Some questions– What kind of care is needed?– For how long?– By whom?– Whose responsibility?
Ancillary care – some examples
• Hypertension– May be diagnosed incidentally during the conduct
of trial procedures– Treatment is lifelong– Management is multi-modal, i.e. requires attention
to weight, nutrition, exercise, in addition to possible pharmacotherapy
• Facilitating access to services– TOP– Psychosocial support – rape/trauma/DV– Mental illness
• Dental care
What is “the standard of prevention”?
• HIV counseling and testing– Some protocols may not provide results in ‘real-
time’, depending on the complexity of ruling out vaccine-induced seropositivity
– Impact on testing outside of the trial setting• Other VCTs, blood donation, organ donation, testing for
insurance purposes
– What about partners?• Should we offer CHCT and who is able to do that?
More “Standard of Prevention”
• Risk reduction counselling– Efforts to standardize that intervention,
such as pilot efforts within DAIDS networks
• Condom promotion vs. provision– Male / Female / both– What other means should be used to
promote condom uptake
What about additional HIV prevention technologies?
• Male circumcision
• STI treatment – Diagnostics– Directed versus syndromic therapy
• Post-exposure prophylaxis
• Pre-exposure prophylaxis
• Other investigational agents
Cochrane Review of HIV and Circumcision in High Risk Heterosexual Men
Siegfried et al. Lancet Infect Dis 2005
Phambili timelines
17Mar06. MCC submission. GMO submission
8May06. HREC submission
12Sep06. IBC submission
13Oct06. MCC approval
19Oct06. HREC approval24Jan07. First pt enrolled
19 Sep 2007
STEP trial interim resultsJuly 2005 Orange Farm MC trial results
December 2006 Kenyan and Ugandan MC trial results
7March 2007 First Phambili participant provided MC
8Nov06. IBC approval
21Nov06. GMO approval
Location of Studies of Acceptability
Thirteen studies from nine sub-Saharan African countries
Bailey R IAS 2007