RecruitingPhase 1

Cabotegravir-Hormone PK/PD Interactions for HIV Prevention

United States32 participantsStarted 2026-07

Plain-language summary

This is a research study to better understand how long-acting cabotegravir (CAB-LA) works to prevent HIV in people. This study will also evaluate the impact of endogenous and therapeutic hormones on CAB-LA pharmacology. The investigators will also evaluate if participants experience any medical problems when taking CAB-LA.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 19 years of age or older * For persons using exogenous hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and exogenous hormone regimens must be prescribed and managed under the care of a healthcare professional * For females, must be on a non-hormonal contraceptive agent, and must persist in contraceptive use for the duration of the study * Body weight greater than 35 kg (77.2 lbs) * HIV-1 uninfected at screening and enrollment as documented by an instrumented Ag/Ab assay and HIV-1 RNA testing * Understand and agree to local STI reporting requirements * Willing to abstain from additional antiretroviral agents (including PrEP agents, F/TAF and F/TDF) during the duration of the study * Willing to abstain from insertion of anything (drug, enema, penis, or sex toy) in the rectum or vagina for 72 hours before and 72 hours after each flexible sigmoidoscopy * Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit * Willing and able to use condoms for all receptive anal intercourse and receptive vaginal intercourse for the duration of study participation * Able and willing to communicate in English * Able and willing to provide written informed consent to take part in the study * Able and willing to provide adequate information for locator purposes * Availability to return for all study visits, barring unforeseen circumstances * Agree not to participate in other …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma CAB concentration

Timeframe: Day 1 (24 h), Day 3 (72 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Plasma CAB area under the concentration curve

Timeframe: 0-12 weeks, AUC inf

Rectal Tissue CAB concentrations

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Rectal Fluid CAB concentrations

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Cervical Tissue CAB concentrations , in females only

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Cervicovaginal Fluid CAB concentrations, in females only

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Trial details

NCT IDNCT07672717

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

Pooja Akoijam

4109551201 pakoija1@jh.edu

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Plasma CAB concentration

Timeframe: Day 1 (24 h), Day 3 (72 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Plasma CAB area under the concentration curve

Timeframe: 0-12 weeks, AUC inf

Rectal Tissue CAB concentrations

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Rectal Fluid CAB concentrations

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Cervical Tissue CAB concentrations , in females only

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12

Cervicovaginal Fluid CAB concentrations, in females only

Timeframe: Day 1 (24 h), Week 1, Week 2, Week 4, Week 8, and Week 12