HIV Infections Clinical Trial
Official title:
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Kenya, Africa
This study will evaluate the safety and acceptability of an intermittent and daily PrEP
regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at
risk for HIV, 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 study will use
objective medication event monitoring medication event monitors (MEMS) adherence measurement
and evaluate the feasibility of newer adherence measurements such as hair sampling and
plasma drug levels. The study will also evaluate the feasibility of using SMS (text
messages) 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. This
study is not sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be
safe, feasible in terms of adherence, and achieves intracellular drug levels similar to
daily PrEP, these data could be used to design a larger phase 2 study with one or more
intermittent PrEP regimens. The goal of such a 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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