Clinical Research at JHP

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

UniversityCollaborated with NAC on

◦HIV sentinel surveillance among pregnant women in Blantyre

COM- 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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