HIV Infection Clinical Trial
Official title:
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
This study will evaluate the safety and acceptability of intermittent and daily pre-exposure
prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in
HIV discordant couples, and it will directly compare adherence and intracellular drug levels
in daily and intermittent PrEP recipients. It will also evaluate the relationship between
drug adherence, sexual behavior and intracellular drug levels with an intermittent PrEP
regimen. In addition it will evaluate the relationship between adherence to an intermittent
PrEP regimen and timing of sexual activity in relation to PrEP dosing. The pilot will use
objective medication event monitoring (MEMS) adherence measurement and evaluate the
feasibility of newer adherence measurements such as hair sampling and plasma drug levels.
This study will also evaluate the feasibility of using text messaging (SMS) to collect
sexual activity data in an African setting. It will allow study teams and communities to
prepare for potential subsequent larger trials of intermittent PrEP. The study is not sized
to evaluate efficacy. If the intermittent PrEP regimen is safe, feasible in terms of
adherence, and achieves intracellular drug levels similar to daily PrEP, the data could be
used to design a larger phase 2 study with one or more intermittent PrEP regimens. The goal
of such a larger trial would be to provide bridging data if daily PrEP regimens are found to
be effective or to prepare for efficacy or non-inferiority trials of intermittent versus
daily PrEP.
Investigation of immune responses associated with FTC/TDF will also be evaluated in the
pilot study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due
to exposures that did not lead to established HIV infection, will be assessed at 2-3 time
points and compared to responses in volunteers assigned to placebo. Immune responses may be
correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.
As noted above, very few HIV infections are expected to occur during the study, so
correlation of HIV-specific immune responses and protection from infection or attenuation of
disease progression will not be possible until a larger study is conducted.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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