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HPTN 052

HPTN 052. A Randomized Trial To Evaluate the Effectiveness of Antiretroviral Therapy to Reduce the Sexual Transmission of HIV-1 in Serodiscordant Couples. ART to Prevent Sexual Transmission of HIV. 1. Biological plausibility 2. Expectations from modeling 3. HPTN052

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HPTN 052

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  1. HPTN 052 A Randomized Trial To Evaluate the Effectiveness of Antiretroviral Therapy to Reduce the Sexual Transmission of HIV-1 in Serodiscordant Couples

  2. ART to Prevent Sexual Transmission of HIV 1. Biological plausibility 2. Expectations from modeling 3. HPTN052 - Protocol Development -Team Building (SOPs) -Site Preparedness and Community Input 4. HPTN/ACTG “Marriage”…and ACTION ITEMS -HPTN052 Plus 5. ART for Prevention: limitations

  3. HPTN 052 ACTION ITEMS 1. Improved infrastructure for 7 PTN sites initiated 2. Piloting HPTN VCT and couples counseling SOP 3. Piloting HPTN primary care services 4. Introducing HPTN ART care services 4. HPTN/ACTG Activities HPTN052 Protocol Review Process Development of HPTN 052 PLUS ACTG/HPTN Expansion (RFA) ACTG/HPTN Training

  4. HPTN 052: The BestCase Scenario • Proof that ART prevents sexual transmission of HIV, sustained • Identification of biomarkers that prospectively predict transmission • Demonstration of safe and effective delivery of ART, with benefit to the individual • Determination of the merits of early vs. late ART • Expansion of prevention results that benefit treatment and prevention activities • Identification of strategies to reduce the probability of resistance

  5. In resource- limited countries: Demand > 30 million infected people A mountain of limitations: Cynicism, Skepticism Ethical and Economic issues Logistical and Public health issues Layers of governmental approval IRB approval, Drug supply, Drug delivery Patient management In the West: Supply & Enthusiasm Required:Commitment and Tenacity ART for Prevention in Developing Countries

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