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Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
Sponsor: University of Alabama at Birmingham
Summary
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.
Official title: Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
105
Start Date
2026-04-01
Completion Date
2026-12-31
Last Updated
2026-04-08
Healthy Volunteers
Yes
Conditions
Interventions
Long-acting injectable cabotegravir (CAB-LA)
Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).
No PrEP
No HIV pre-exposure prophylaxis administered
Locations (1)
Princess Marina Hospital
Bontleng, Gaborone, Botswana