1. Clinical Research at JHP LNM – 02 October 2012

2. OutlineJHU- Administration Building History Influential studies- ◦ PEPI ◦ 052 Future Prospects

3. 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

4. Network Overview 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.

5. High lights PEPI- Extended Infant post exposure Prophylaxis with antiretrovirals to reduce postnatal HIV transmission HPTN 052- The Sero discordant Trial

6. 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

7. 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

8. Primary Objective Objective- To determine the rate of HIV Infection at 9 months

9. 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

10. 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

11. 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

12. 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.

13. 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.

14. 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.

15. What are your questions?