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New treatment option for HIV Infections
Official title The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
ClinicalTrials.gov ID: NCT05515770
What this study is testing
What is Cabotegravir Injection?
Cabotegravir Injection is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv infections.
Also referred to as brand name: Apretude.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation strategies. The proposed implementation study will assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30, men only. Healthy volunteers may be eligible.
You may be able to join if
- Cisgender men, non-binary (assigned as male at birth) or transgender women and men
- Report having anal sex with a person assigned male at birth in the last six months (Persons born female having sex only with other persons born...
- Age 18-30 years
- Seek a study clinic looking for PrEP
- CAB LA and TDF/FTC PrEP naïve
You likely can't join if
- One or more reactive or positive HIV test result at enrollment visit, even if HIV infection is not confirmed.
- Currently participating in treatment trial of PrEP agents, HIV vaccine trial or experimental medication.
- Positive pregnancy test, breastfeeding, or intention to become pregnant at enrolment (for transgender men).
- Prior participation in studies with Cabotegravir.
- A history or presence of allergy to the study drug components.
- Past participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active...
See the full eligibility criteria
- Cisgender men, non-binary (assigned as male at birth) or transgender women and men
- Report having anal sex with a person assigned male at birth in the last six months (Persons born female having sex only with other persons born female are excluded)
- Age 18-30 years
- Seek a study clinic looking for PrEP
- CAB LA and TDF/FTC PrEP naïve
- Willing and able to provide written informed consent and adhere to the study requirements
- Non-reactive / negative HIV test results, including both HIV rapid tests and an undetectable HIV RNA at enrollment for individuals choosing injectable CAB-LA.
- No report of hepatic dysfunction. Candidates reporting liver disease will have their enrollment visit postponed until laboratory results of liver function are available. Individuals with ALT \>=5x ULN, OR ALT\>=3xULN...
- Willing to undergo all required study procedures.
- One or more reactive or positive HIV test result at enrollment visit, even if HIV infection is not confirmed.
- Currently participating in treatment trial of PrEP agents, HIV vaccine trial or experimental medication.
- Positive pregnancy test, breastfeeding, or intention to become pregnant at enrolment (for transgender men).
- Prior participation in studies with Cabotegravir.
- A history or presence of allergy to the study drug components.
- Past participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm).
- Plan to relocate out of the area during the study period.
- Surgically placed or injected buttock implants or fillers, per self-report.
- Has a dermatological/inflammatory skin condition overlying the buttock region which in the opinion of the study investigator, in consultation with the Clinical Study Coordination (CSC), may interfere with interpretation...
- Active or planned use of contraindicated co-administered for which significant decreases in Cabotegravir plasma concentrations may occur due uridine diphosphate glucuronosyltransferase (UGT1A1):
- Anticonvulsants: Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin
- Antimycobacterials: Rifampin, Rifapentine \ Any prohibited medications that decrease CAB concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to...
- Current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding.
- History of severe hepatic impairment (including but not limited to a history of liver failure or hospitalization for liver disease, a history of hepatocellular carcinoma or near liver transplant).
- Individuals with advanced Hepatitis C.
- Other medical conditions that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical).
The study team makes the final eligibility decision.
Where it's taking place
- Rio de Janeiro, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rio de Janeiro, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.