Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Sponsor
University of Alabama at Birmingham
Study ID
NCT07516548
Status
Not Yet Recruiting

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Conditions

  • Contraception
  • Drug-drug Interaction
  • HIV Infections
  • Long-acting Injectable Cabotegravir for PrEP
  • PrEP

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Long-acting injectable cabotegravir (CAB-LA) — DRUG
    Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).
  • No PrEP — OTHER
    No HIV pre-exposure prophylaxis administered

Study Details

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.

Key Dates

First listed
Apr 8, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
105 participants (estimated)

Arms

  • Arm: Group 1: CAB-LA + IM DMPA
    Injectable cabotegravir 600mg + intramuscular depo-medroxyprogesterone acetate 150mg (IM DMPA)
  • Arm: Group 2: CAB-LA + ETG implant
    Injectable cabotegravir 600mg + etonogestrel (ETG) implant 68mg
  • Arm: Group 3: CAB-LA + no hormonal method
    Injectable cabotegravir 600mg + no hormonal method
  • Arm: Group 4: No PrEP + IM DMPA
    No PrEP + intramuscular depot medroxyprogesterone acetate (IM DMPA) 150mg
  • Arm: Group 5: No PrEP + ETG implant
    No PrEP + etonogestrel (ETG) implant 68mg

Primary Outcome Measure

To evaluate any associations between CAB-LA exposure and hormonal contraceptive use in the three groups of IM DMPA, ETG implant, and non-hormonal method users by generating geometric mean hormone concentrations (Aim 1a) [ Time Frame: 0, 4, 8, 12 weeks for IM DMPA; 0, 4, 8, 12, 24 weeks for ETG implant and non-hormonal method users ]

Central Contacts

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