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This outline presents a comprehensive overview of the clinical research efforts by JHP LNM since 1988. Key collaborations with the Ministry of Health and JHU University focus on HIV sentinel surveillance among pregnant women, with significant studies such as PEPI and HPTN 052 revealing promising results in reducing HIV transmission. The PEPI study demonstrated reduced postnatal HIV infection in infants through extended infant post-exposure prophylaxis. HPTN 052 highlighted a 96% reduction in HIV transmission in sero-discordant couples through early antiretroviral treatment.
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Clinical Research at JHP LNM – 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 Blantyre • COM- major partner • Most Investigators are Faculty of COM
Other Studies…. Nursing Team in a Clinic • HIV Vaccine- Vaccine Network • Microbicides- MTN • Mother to Child Transmission- IMPAACT • Incidence Studies- NAC • Treatment Trials- ACTG • CAG. Network Overview
High lights • PEPI- 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 Objective • Objective- To determine the rate of HIV Infection at 9 months
PEPI Results • Enrolled 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
Results • At 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 052 A 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.
Results • HPTN 052, which demonstrated a 96 percent reduction in HIV transmission among HIV serodiscordant couples when the HIV-positive partner received early antiretroviral treatment.