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New HIV prevention pill shows promise in large trial

NCT ID NCT02842086

Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This phase 3 study tested a daily pill called F/TAF (Descovy) to prevent HIV infection in nearly 5,400 men and transgender women who have sex with men and are at high risk. Participants took either F/TAF or the existing prevention drug Truvada. The goal was to see if F/TAF is as safe and effective at preventing HIV, with potential benefits for bone and kidney health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
emtricitabine/tenofovir alafenamide (F/TAF, also known as Descovy)
What this could lead to
If successful, this could provide a new daily pill option for preventing HIV infection with potentially fewer side effects on bone and kidney health.
What could go wrong
This is a large phase 3 trial, but results may not apply to all populations. The drug must be taken daily, and no prevention method is 100% effective. Long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

5,399 people

The number who actually took part.

Started

Sep 2016

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Must be at high risk of sexual acquisition of HIV * HIV-1 negative status * MSM and TGW (male at birth) who have at least one of the following: * condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status) * documented history of syphilis in the past 24 weeks * documented history of rectal gonorrhea or chlamydia in the past 24 weeks * Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula * Adequate liver and hematologic function: * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin * Absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 75,000/mm\^3; hemoglobin ≥ 10 g/dL Key Exclusion Criteria * Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable. NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-exposure prophylaxis of HIV-1 infection

Contacts and locations

Locations

  • Study site

    Beverly Hills, California, 90211, United States

  • Study site

    Los Angeles, California, 90036, United States

  • Study site

    Los Angeles, California, 90069, United States

  • Study site

    Newport Beach, California, 92663, United States

  • Study site

    Oakland, California, 94609, United States

  • Study site

    Sacramento, California, 95817, United States

  • Study site

    Sacramento, California, 95825, United States

  • Study site

    San Diego, California, 92103, United States

  • Study site

    San Francisco, California, 94102, United States

  • Study site

    San Francisco, California, 94103, United States

  • Study site

    San Francisco, California, 94118, United States

  • Study site

    Torrance, California, 90502, United States

  • Study site

    Aurora, Colorado, 80045, United States

  • Study site

    Denver, Colorado, 80209, United States

  • Study site

    New Haven, Connecticut, 06510, United States

  • Study site

    Washington D.C., District of Columbia, 20009, United States

  • Study site

    Washington D.C., District of Columbia, 20036, United States

  • Study site

    Fort Lauderdale, Florida, 33308, United States

  • Study site

    Fort Lauderdale, Florida, 33316, United States

  • Study site

    Ft. Pierce, Florida, 34982, United States

  • Study site

    Miami, Florida, 33136, United States

  • Study site

    Orlando, Florida, 32803, United States

  • Study site

    Pensacola, Florida, 32504, United States

  • Study site

    West Palm Beach, Florida, 33407, United States

  • Study site

    Atlanta, Georgia, 30308, United States

  • Study site

    Atlanta, Georgia, 30309, United States

  • Study site

    Atlanta, Georgia, 30312, United States

  • Study site

    Macon, Georgia, 31201, United States

  • Study site

    Chicago, Illinois, 60612, United States

  • Study site

    Chicago, Illinois, 60613, United States

  • Study site

    New Orleans, Louisiana, 70119, United States

  • Study site

    Boston, Massachusetts, 02215, United States

  • Study site

    Springfield, Massachusetts, 01105, United States

  • Study site

    Berkley, Michigan, 48072, United States

  • Study site

    Detroit, Michigan, 48202, United States

  • Study site

    Minneapolis, Minnesota, 55415, United States

  • Study site

    Las Vegas, Nevada, 89104, United States

  • Study site

    Somers Point, New Jersey, 08244, United States

  • Study site

    Santa Fe, New Mexico, 87505, United States

  • Study site

    New York, New York, 10029, United States

  • Study site

    New York, New York, 10032, United States

  • Study site

    New York, New York, 10037, United States

  • Study site

    The Bronx, New York, 10467, United States

  • Study site

    Chapel Hill, North Carolina, 27599-7215, United States

  • Study site

    Huntersville, North Carolina, 28078, United States

  • Study site

    Cleveland, Ohio, 44109, United States

  • Study site

    Philadelphia, Pennsylvania, 19107, United States

  • Study site

    Austin, Texas, 78705, United States

  • Study site

    Dallas, Texas, 75208, United States

  • Study site

    Dallas, Texas, 75246, United States

  • Study site

    Houston, Texas, 77098, United States

  • Study site

    Seattle, Washington, 98101, United States

  • Study site

    Seattle, Washington, 98104, United States

  • Study site

    Milwaukee, Wisconsin, 53226, United States

  • Study site

    Graz, 8051, Austria

  • Study site

    Vienna, 1090, Austria

  • Study site

    Vancouver, British Columbia, V6Z 2T1, Canada

  • Study site

    Toronto, Ontario, M5G 1K2, Canada

  • Study site

    Montreal, Quebec, H2l 4P9, Canada

  • Study site

    Montreal, Quebec, H2L5B1, Canada

  • Study site

    Montreal, Quebec, H2W 1T8, Canada

  • Study site

    Hvidovre, Capital Region, 2650, Denmark

  • Study site

    Aarhus N, Central Jutland, 8200, Denmark

  • Study site

    Copenhagen, RegionH, 2100, Denmark

  • Study site

    Odense, 5000, Denmark

  • Study site

    Nice, Alpe Maritimes, 6202, France

  • Study site

    Marseille, Provence, 13006, France

  • Study site

    Paris, Provence, 75020, France

  • Study site

    Paris, 75475, France

  • Study site

    Munich, Bavaria, 81675, Germany

  • Study site

    Berlin, 10439, Germany

  • Study site

    Berlin, 10777, Germany

  • Study site

    Frankfurt, 60596, Germany

  • Study site

    Dublin, Dublin, D07 A8NN, Ireland

  • Study site

    Dublin, 8, Ireland

  • Study site

    Milan, 20127, Italy

  • Study site

    Roma, 00149, Italy

  • Study site

    Amsterdam, Netherlands

  • Study site

    Badalona, Barcelona, 08907, Spain

  • Study site

    Barcelona, 08015, Spain

  • Study site

    Madrid, 28010, Spain

  • Study site

    Vigo, 36312, Spain

  • Study site

    Soho, London, W1D 6AQ, United Kingdom

  • Study site

    Whitechapel, London, E1 1BB, United Kingdom

  • Study site

    Edinburgh, Scotland, EH3 9HA, United Kingdom

  • Study site

    Brighton, Sussex, BN2 1ES, United Kingdom

  • Study site

    Birmingham, B9 5SS, United Kingdom

  • Study site

    London, E9 6SR, United Kingdom

  • Study site

    London, SE18 4QH, United Kingdom

  • Study site

    London, SE5 9RJ, United Kingdom

  • Study site

    London, W2 1NY, United Kingdom

  • Study site

    London, WC1E 6JB, United Kingdom

  • Study site

    Manchester, M13 0FH, United Kingdom