Pre-Exposure Prophylaxis (PrEP) Implementation study of long-acting injectable cabotegravir (CAB-LA)

Not Applicable

Recruiting

• Conditions: Contact with or exposure to human immunodeficiency virus; B04.820.650.589.650.350

• Registration Number: RBR-8s3qz5s
• Lead Sponsor: Instituto Nacional de Infectologia Evandro Chagas - INI/Fiocruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-29
• Last Update Posted: 19 December 2023
• Study Completion: 2026-08-02

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Cisgender, non-binary (assigned male at birth) or transvestite men, transgender men and women; Report of anal sex in the past six months with a person who was assigned male at birth (Persons born female who have had sex only with people born female are excluded); Age from 18 to 30 years old; Report to the study center looking for PrEP;
PrEP-naïve with CAB LA or oral PrEP with TDF/FTC; Willing and able to provide written informed consent and adhere to study requirements; Non-reactive/negative HIV test results, including rapid HIV tests and an undetectable HIV RNA test at enrollment for individuals who choose injectable CAB-LA; No reports of liver dysfunction. Applicants who report liver disease will have their enrollment visit postponed until laboratory results of liver function tests are available. See Section 7 (Study Procedures - Inclusion Visit); Willing to undergo all necessary study procedures.

Exclusion Criteria

One or more reactive or positive HIV test results at the enrollment visit, even if HIV infection is not confirmed; Currently participating in a PrEP agent intervention trial, HIV vaccine trial, or experimental medication trial; Positive pregnancy test, breastfeeding or intent to become pregnant during study enrollment (for trans men); Previous participation in studies with Cabotegravir; History or presence of allergy to study drug components; Past participation in an HIV vaccine trial. An exception will be made for participants who can provide documentation of placebo receipt (non-active arm); Planning to relocate outside the area during the study period; Injected or surgically placed buttock implants or fillers, by self-report; Have 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 the interpretation of injection site reactions; Active or planned use of a contraindicated co-administered drug for which significant decreases in plasma concentrations of Cabotegravir may occur due to uridine diphosphate glucuronosyltransferase (UGT1A1): • Anticonvulsants: Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin • Antimycobacterial: Rifampicin, Rifapentine; Current or anticipated need for chronic systemic anticoagulation or history of known or suspected bleeding disorder, including history of prolonged bleeding; History of severe liver failure (including, but not limited to, history of liver failure or hospitalization for liver disease, history of hepatocellular carcinoma or near liver transplant); Individuals with advanced Hepatitis C; Other medical conditions that, in the opinion of the study investigator, interfere with the conduct of the study (eg, provided by self-report or found by the physician).

Study & Design

• Study Type: Intervention
• Study Design: Not specified