Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Study acronym: PHARAOH
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 2026 → Dec 2026
See other at-risk trials from University of Alabama at Birmingham

Record History

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  1. Primary and study completion pushed from Oct 2026 to Dec 2026
  2. Recruitment opened Show 6 more changesShow less
    • Primary and study completion moved earlier from Dec 31, 2026 to Oct 2026
    • Start date changed from estimate of Aug 1, 2026 to Jan 24, 2025
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 6 words
    • Site details revised
  3. Start date: Jun 1, 2026 to Aug 1, 2026v3
  4. Start date: Apr 1, 2026 to Jun 1, 2026v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.
Trial Details
NCT Number NCT07516548
Lead Sponsor University of Alabama at Birmingham
Collaborators: Beth Israel Deaconess Medical Center, University of Nebraska, National Institute of Allergy and Infectious Diseases (NIAID), Botswana Harvard Health Partnership
Conditions
(from sponsor)		 HIV Infections, Contraception, Drug-drug Interaction, PrEP, Long-acting Injectable Cabotegravir for PrEP
Related terms HIV Infections
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov