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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 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. The trial reports 20 study locations across 5 states.

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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.

Conditions Studied

Pre-Exposure Prophylaxis of HIV-1 Infection

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

504 total trials

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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, categorized as Phase 3. 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 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.