FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women (NCT00625404) | Clinical Trial Compass
CompletedPhase 3
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Kenya, South Africa, Tanzania2,120 participantsStarted 2009-05
Plain-language summary
This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.
The study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo.
After enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
. Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
. Between 18-35 years old, inclusive
. At higher risk of becoming HIV infected
. Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm
. Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HIV Infection
Timeframe: Cumulative HIV infection between enrollment and 52 weeks
2
Confirmed Grade 2 or Higher Serum Creatinine Toxicity
Timeframe: cumulative toxicity through 52 weeks of product use and 4 weeks post product
3
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
Timeframe: 10-26 months per site
4
Confirmed Grade 3 or Higher Reduction in Phosphorus
Timeframe: Through 52 weeks on product and 4 weeks post-product
5
Confirmed Grade 3 or Higher ALT Elevation
Timeframe: Through 52 weeks on product and 4 weeks post-product
6
Confirmed Grade 3 or Higher AST Elevation
Timeframe: Through 52 weeks on product and 4 weeks post-product
. Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( \> 1 month at a time)
. In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation