Twice-Yearly HIV prevention shot shows promise in women

NCT ID NCT06101329

Ongoing Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new long-acting injection called lenacapavir, given every 6 months, to prevent HIV in cisgender women in the US. About 253 women will receive either the injection or daily pills (Truvada) to compare how well the drug works in the body, its safety, and how acceptable it is. The goal is to see if a twice-yearly shot could be a convenient alternative to daily medication for HIV prevention.

What this could mean

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

Active substance: lenacapavir (injection and tablet) and emtricitabine/tenofovir disoproxil fumarate (Truvada)
What this could lead to: If successful, this could offer a convenient twice-yearly injection option for HIV prevention, reducing the need for daily pills.
What could go wrong: This is an early phase 2 study with only 253 women, so results may not apply to everyone. Side effects or low acceptability could limit its use.

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

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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 INFECTION

Contacts and locations

Locations

Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10010, United States
Fenway Health

Boston, Massachusetts, 02215, United States
George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States
Harlem Prevention Center CRS

New York, New York, 10027, United States
ICAP at Columbia University - Bronx Prevention Center

The Bronx, New York, 10451, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
Penn Prevention Research Unit

Philadelphia, Pennsylvania, 19104, United States
Ponce de Leon Center Clinical Research Site

Atlanta, Georgia, 30303, United States
Rutgers New Jesey Medical School - Clinical Research Center

Newark, New Jersey, 07103, United States
UAB, 1917 Research Clinic

Birmingham, Alabama, 35222, United States
UCSD Antiviral Research Center (AVRC)

San Diego, California, 92103, United States

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