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NCT02842086 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
A Phase 3 study of Pre-Exposure Prophylaxis of HIV-1 Infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 5,399
- Enrollment target
- 20
- Study locations
NCT02842086: Active Phase 3 study of Pre-Exposure Prophylaxis of HIV-1 Infection, sponsored by Gilead Sciences.
NCT02842086 is a Phase 3 study of Pre-Exposure Prophylaxis of HIV-1 Infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 5,399 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (599% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02842086, a Phase 3 study of Pre-Exposure Prophylaxis of HIV-1 Infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,399 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.
Primary Outcome
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screeni
Conditions Studied
Interventions
- DRUG F/TDF
- DRUG F/TAF
- DRUG F/TAF Placebo
- DRUG F/TDF Placebo
Study Locations (20)
California
- - Beverly Hills
- - Los Angeles
- - Los Angeles
- - Newport Beach
- - Oakland
- - Sacramento
- - Sacramento
- - San Diego
- - San Francisco
- - San Francisco
- - San Francisco
- - Torrance
Florida
- - Fort Lauderdale
- - Fort Lauderdale
- - Ft. Pierce
Colorado
- - Aurora
- - Denver
District of Columbia
- - Washington D.C.
- - Washington D.C.
Connecticut
- - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,399 participants |
| Start Date | 2016-09-02 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT02842086 still lists
NCT02842086 is an interventional study that assigns participants to a tested intervention. Its 5,399 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (599% higher).
The record links to 1 condition, with Pre-Exposure Prophylaxis of HIV-1 Infection appearing as the primary indexed condition, and to 4 interventions - of which F/TDF is the first listed.
NCT02842086 names 20 study sites across 5 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT02842086 about?
NCT02842086 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection". The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 4...
What is the current status of trial NCT02842086?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,399 participants. The study started on 2016-09-02. Estimated completion is 2027-09.
What conditions does trial NCT02842086 study?
This clinical trial studies the following conditions: Pre-Exposure Prophylaxis of HIV-1 Infection.
What interventions are being tested in trial NCT02842086?
The interventions under investigation include: F/TDF (DRUG), F/TAF (DRUG), F/TAF Placebo (DRUG), F/TDF Placebo (DRUG).
Who is sponsoring clinical trial NCT02842086?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02842086 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02842086's enrollment target sits among peer trials
5,399 45th of 2000 higher than 1,956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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