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Clinical Research at JHPLNM – 02 October 2012
Outline JHU- Administration Building
History Influential studies-
◦ PEPI
◦ 052
Future Prospects
HISTORY……….
Started in 1988- MOH and JHU University
Collaborated with NAC on ◦HIV sentinel surveillance among
pregnant women in BlantyreCOM- major partner
◦Most Investigators are Faculty of COM
Network Overview
Other Studies…. Nursing Team in a Clinic
HIV Vaccine- Vaccine Network
Microbicides- MTNMother to Child
Transmission- IMPAACT
Incidence Studies- NAC
Treatment Trials- ACTG
CAG.
High lightsPEPI- Extended Infant post
exposure Prophylaxis with antiretrovirals to reduce postnatal HIV transmission
HPTN 052- The Sero discordant Trial
Design
This was a randomized, controlled Phase III trial of extended post-exposure prophylactic antiretroviral to the baby to prevent breast milk-associated HIV transmission
Design
Three arm study◦ Control Sd NVP +ZDV for
1 week
◦ ARM 1- Control Regimen + NVP for 14 weeks
◦ ARM 2- Control Regimen + NVP and ZDV for 14 weeks
Primary ObjectiveObjective- To determine the rate
of HIV Infection at 9 months
PEPI ResultsEnrolled 3335/3398 mother
infant since 2004-2007
Results◦Among 3016 infants- the control
group had consistently higher rates of HIV infection from 6wks of age thru 18 months
ResultsAt 9 months HIV infection was as
follows◦In control arm 10.6%◦NVP arm 5.2%◦NVP and ZDV- 6.4%
Conclusion- Ext Prophylaxis for the first 14 weeks of life reduced postnatal HIV infection in 9 months old infants
HPTN 052A randomized trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in sero-discordant couples
Objective
To evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in sero -
discordant couples.
Design
Multi site 1750 couples all site, 230 couples Blantyre site alone.
The study consists of 2 cohorts
Cohort 1: ART upon enrollment plus HIV primary care.
Cohort 2: HIV primary care without initiation of ART until the participant has two consecutive measurements of a CD4+ cell count < 200 cells/mm, or develops an AIDS-defining illness.
ResultsHPTN 052, which demonstrated a 96
percent reduction in HIV transmission among HIV serodiscordant couples when the HIV-positive partner received early antiretroviral treatment.
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