Study Design
Protocol title: Chemoprophylaxis for HIV Prevention in
Men
Sites: Lima and Iquitos in Peru; Guayaquil in Ecuador;
San Francisco and Boston in the USA; Sao Paulo and Rio de Janeiro
in Brazil; Cape Town in South Africa and Chiang Mai in Thailand.
Starting date: June 18, 2007.
Planned ending date: December 2010
Study rationale: A randomized, double-blind, placebo-controlled
clinical trial is required to determine if daily oral co-formulated
emtricitabine 200 mg/tenofovir 300 mg (FTC/TDF) decreases HIV-1 acquisition
and has acceptable safety in initially HIV-uninfected men who are
receiving standard prevention interventions.
Objectives:
-
To determine if placebo and daily oral FTC/TDF are safe in HIV-1
uninfected men who have sex with men (MSM)
-
To determine if daily
oral FTC/TDF reduces HIV-1 seroincidence among HIV-1 uninfected
MSM (prevents HIV-1 infection)
Primary endpoints: Adverse events and HIV-1 seroconversion.
Design:
- A
Phase III randomized, double-blind, placebo-controlled study of the safety and
efficacy of chemoprophylactic FTC/TDF administered orally once daily to men
at high risk for acquiring HIV-1.
- Event
-driven study that plans to enroll 3000 HIV-1 seronegative MSM who will be randomized
to receive either FTC/TDF daily (N = 1500) or FTC/TDF placebo daily (N = 1500)
in addition to standard counseling, condoms, and STI management.
Study agent: Emtricitabine (FTC 200 mg) and tenofovir
(TDF 300 mg). FTC and TDF are reverse transcriptase inhibitors that
have been licensed for the treatment of HIV-1 infection in humans by
the U.S. Food and Drug Administration (FDA).
Duration:
- Participants
will begin taking the study drug within 4 weeks after their screening visit.
Follow-up of participant taking the study drug may be as short as 48 weeks or
as long as 144 weeks. Participants will be followed on study drug until the
last enrolled participant has completed 48 weeks on study drug follow-up.
- All
participants will be followed for at least 8 weeks after they stop taking the
study drug.
- Participants
reactive to hepatitis antigens will be followed for hepatitis flares for 16
additional weeks, for a total of 24 weeks after stopping the study drug.
- Participants
enrolled in the optional sub study of bone mineral density, fat distribution,
and fasting lipids will be asked to return for one additional visit 24 weeks
after stopping the study drug.
- Participants
who HIV seroconvert during their participation in the study will also be followed
until the end of study drug follow-up, and for at least 24 weeks after study
participants stop taking the study drug.
Inclusion/exclusion criteria:
- Potential
participants must be men, have sex with men, have reached the local age of consent,
HIV-1 uninfected, not acutely infected with hepatitis B, in good health, and
engage in high-risk sexual behavior for HIV acquisition.
- Each
potential participant must be physically capable of providing blood and urine
for safety assessments.
- Each
participant must understand the protocol procedures and provide written informed
consent.
Treatment regime:
- FTC/TDF orally once daily versus matching placebo.
- All participants
will receive standard counseling, condoms, and management of STIs
Evaluation:
All participants will be evaluated at intervals of 4 weeks
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