Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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

NCT02842086 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 5,399 participants
Start Date 2016-09-02
Est. Completion 2027-09
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02842086

The ClinicalTrials.gov registry entry for NCT02842086 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,399 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02842086 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02842086?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial