Twice-Yearly HIV prevention shot shows promise in women

NCT ID NCT06101329

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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