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NOT YET RECRUITING
NCT07516548

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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

Interventions

DRUG

Long-acting injectable cabotegravir (CAB-LA)

Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).

OTHER

No PrEP

No HIV pre-exposure prophylaxis administered

Locations (1)

Princess Marina Hospital

Bontleng, Gaborone, Botswana