Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV (NCT07516548) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
Botswana105 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female 18 years of age or older and willing and able to provide an informed consent
✓. \< 14 days after delivery (calendar day of birth = day 0)
✓. Negative HIV screening test (conducted at the time of enrolment)
✓. Female \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
✓. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months
Exclusion criteria
✕. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
✕. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)
✕. Previous hypersensitivity reaction to CAB or other INSTI
✕. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months
What they're measuring
1
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)
Timeframe: 0, 4, 8, 12 weeks for IM DMPA; 0, 4, 8, 12, 24 weeks for ETG implant and non-hormonal method users
2
To evaluate any associations between hormonal contraceptive exposure and CAB-LA use by generating geometric mean trough CAB-LA concentrations measured immediately prior to dosing of next CAB-LA (Aim 1b)
Timeframe: Immediately prior to each scheduled CAB-LA injection