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Recruiting NCT07516548

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Conditions: HIV Infections, Contraception, Drug-drug Interaction, PrEP, Long-acting Injectable Cabotegravir for PrEP

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 105
Sponsor: University of Alabama at Birmingham

Location: Princess Marina Hospital Bontleng Gaborone

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.

Eligibility Criteria

Parent Tshireletso Study Inclusion Criteria: 1. Female 18 years of age or older and willing and able to provide an informed consent 2. \< 14 days after delivery (calendar day of birth = day 0) 3. Negative HIV screening test (conducted at the time of enrolment) 4. Female \1 dose oral/IV), or St. John's wort 2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin) 3. Previous hypersensitivity reaction to CAB or other INSTI 4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months 5. Plan for pediatric and post-partum care outside the government system (private clinics) 6. Inflammatory skin condition that compromises the safety of the intramuscular injection 7. Weight \18 years, 4. ability to speak English or Setswana 5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery 6. have access to a cell phone (including phone of friend or relative) Parent Doris Duke Study Exclusion Criteria Post-partum females excluded if 1. did not attend antenatal care or were not included in Tsepamo surveillance 2. maternal age \5x ULN at the time of screening, 2. Serum creatinine \>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI/designee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07516548). StuddyBuddy aggregates publicly available trial information.