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Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

NCT07516548 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • University of Nebraska

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Botswana Harvard Health Partnership

    collaborator UNKNOWN

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Rena Patel, MD, MPH, MPhil · University of Alabama at Birmingham

  • Rebecca Zash · Division of Infectious Disease Beth Israel Deaconess Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Botswana

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516548 on ClinicalTrials.gov