Phase 3 HIV and AIDS Trial, Recruiting NCT07071623 Sponsor: Merck Sharp & Dohme LLC Condition: HIV and AIDS
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Phase 3 HIV and AIDS Trial, Recruiting

NCT07071623
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have tested negative for HIV (both HIV-1 and HIV-2)
  • People who have been sexually active, specifically having had vaginal intercourse with a cisgender male partner at least twice in the last 3 months
  • People who were assigned female sex at birth and identify as cisgender
  • People who weigh 35 kg (approximately 77 pounds) or more

Who may not be able to join:

  • People who have a known allergy or medical reason to avoid any ingredient in the study treatment
  • People who have a current or long-term hepatitis B infection
  • People who have been diagnosed with cancer in the last 5 years (certain treated skin cancers or early-stage cervical cancer may be exceptions — confirm with trial site)
  • People who have previously taken cabotegravir, lenacapavir, or any other long-acting HIV prevention medication
  • People who are currently taking, or who may need to take, certain medications that are not permitted during the study period, starting from 30 days before the study begins (confirm with trial site for the specific list)
  • People who have ever received an HIV vaccine (for example, through a past research study), or who have received certain antibody treatments related to HIV within the 12 months before the study starts

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
10 November 2025
Est. completion
18 October 2027

Where this trial is recruiting

Kenya 🇿🇦 South Africa Uganda

Primary endpoints

Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection; Number of Participants who Experience At Least One Adverse Event (AE); Number of Participants who Discontinue Study Intervention Due to an AE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov