Popping a Pill to Prevent HIV

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Popping a Pill to Prevent HIV?

• A Pre-exposure Prophylaxis HIV-prevention Trial
  in Peru

Pedro Goicochea Co-Investigator, Communications
Director J. Jeff McConnell Co-Investigator,
Protocol Sociologist HIV Prevention Policy,
Activism, and Social Justice Tuesday, April
25th LGBT Community Center208 West 13th Street,
New York City
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Regions Where Most Research is Done
Regions Where Most Of The Epidemic Is
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Why Peru?

• Outstanding Collaborators
• Top international site for NIH prevention,
  vaccine and treatment research
• High Incidence in MSM like the US
• 1 in 20/year
• Subtype B Epidemic like the US

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Proposed Peru PrEP Trial

• 1400 High Risk MSM
• Randomized 11 PrEP vs Placebo
• Followed Over 20 Months For
• HIV Infection
• Adverse Events (especially renal liver)
• Sexual Behavior
• Side Effects
• Adherence
• If infected
• Drug Resistance
• Viral load CD4

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Unique Features of the Peru PrEP Trial

• Powered To Detect Efficacy In MSM
• Intensive Analysis of Safety As Well
• To Be Performed Under FDA IND
• Also Monitored By 5 Other Agencies
• Will Test of PrEP in the Immune system
• Will be Conducted in Peru

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Impacta HIV Research Portfolio in Peru
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WHY PERU Elaborate Gay Culture
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WHY PERU Active Independent Community Advisory
Boards
BRIDGES
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Community Development
Workshops
Open Houses
Community Education
Sports
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Opportunities and Lessons Learned So Far

• PrEP Research in Peru
• New Models For Designing Research
• Community based
• Requires the support of local political
  leadership
• We need the stakeholders involved in research
  design

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Señor Ministro de Salud  qué hacer?Ah!
desgraciadamente, hombres humanos,hay, hermanos,
muchísimo que hacer! LOS NUEVE MONSTRUOS César
Vallejo, 1939
THE NINE MONSTERS Mr. Minister of Health What
to do? Ay, unfortunately, fellow humans, there
is, brothers, so much to do!
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NIH/Peru PrEP Leadership
Protocol Chairs - Robert M Grant (GIVI/UCSF) -
Javier Lama (Lima) - Martin Casapia (Iquitos)

• Medical/Metabolic
• - Vivian Levy (GIVI/Stanford)
• Kathleen Mulligan (UCSF)
• David Burns (NIH)
• - Juan Guanira (Lima)

Coordination - Vanessa McMahan (GIVI) - Oscar
Guerra (Lima)
Statistics/Data - David Glidden (UCSF) - Darryl
Pahl (Seattle) - Jesus Peinado (Lima)
Epidemiology - Jorge Sanchez (Lima) - Kim
Page-Shafer (UCSF)
Laboratory - Douglas Nixon (GIVI) - Carmela
Ganoza (Lima)
Sociology/Communications - Jeff McConnell
(GIVI) - Pedro Goicochea (Lima)
Pharmacy - Ana Martinez (NIH) - Esmelin Perez
(Lima)