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Clinical Research at JHP

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

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Clinical Research at JHP

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  1. Clinical Research at JHP LNM – 02 October 2012

  2. Outline JHU- 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. 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

  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?

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