Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women … (NCT02720094) | Clinical Trial Compass
CompletedPhase 2/3
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
United States, Argentina, Brazil4,570 participantsStarted 2016-12-19
Plain-language summary
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Who can participate
Age range
18 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:
* MSM and TGW, 18 years or older at the time of screening (male at birth)
* Willing to provide informed consent for the study
* At high risk for sexually acquiring HIV infection based on self-report of at least one of the following:
* Any condomless receptive anal intercourse in the 6 months prior to enrollment (condomless anal intercourse within a monogamous HIV seronegative concordant relationship does not meet this criterion)
* More than five partners in the 6 months prior to enrollment (regardless of condom use and HIV serostatus, as reported by the enrollee)
* Any stimulant drug use in the 6 months prior to enrollment
* Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to enrollment
* SexPro score of less than or equal to 16 (U.S. sites only)
* In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment:
* Non-reactive / negative HIV test results. More information on this criterion can be found in the protocol.
* Hemoglobin greater than 11 g/dL,
* Absolute neutrophil count greater than 750 cells/mm\^3
* Platelet count greater than or equal to 100,000/mm\^3
* Calculated creatinine clearance greater than or equal to 60 mL/minute using the Cockcroft-Gault equation (use sex at birth for calculation)
* Although not protocol exclusionary, sites should carefully consider the advisability of enrolling parti…
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
1
Number of Participants With Documented Incident HIV Infections During Steps 1 and 2
Timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
2
Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events
Timeframe: Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).
Trial details
NCT IDNCT02720094
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)