Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Cabotegravir; Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• Assigned male at birth (includes MSM, TGW, and gender non-conforming people)

• At enrollment, aged below 18 years

• At enrollment, body weight ≥ 35 kg (77 lbs.)

• Willing to provide informed consent for the study

• Self-reported sexual activity with a male in the past 12 months

• In general, good health, as evidenced by the following laboratory values

• Non-reactive/negative HIV test results

• Absolute neutrophil count > 799 cells/mm3

• Platelet count ≥ 100,000 cells/mm3

• Hemoglobin ≥ 11g/dL

• Calculated creatinine clearance ≥ 60 mL/minute using modified Schwartz equation (≤ grade 2)

• Alanine aminotransferase (ALT) < 2.0 times the upper limit of normal (ULN) and total bilirubin (Tbili) ≤ 2.5 x ULN

• Hepatitis B virus (HBV) surface antigen (HBsAg) negative and accepts vaccination

• Hepatitis C virus (HCV) Antibody negative

• Willing to undergo all required study procedures

• If currently on pre-exposure prophylaxis (PrEP) from a non-study source, willing to stop said PrEP prior to enrollment and agree to switch to oral CAB for the lead-in period and CAB LA injections.

Exclusion Criteria:

• Co-enrollment in any other HIV interventional research study or other concurrent studies which may interfere with this study (as provided by self-report or other available documentation)

• Past or current participation in HIV vaccine trial with exception for participants who can provide documentation of receipt of placebo

• Exclusively had sex with biological females in lifetime

• In the last 6 months (at the time of screening): active or planned use of any substance which would, in the opinion of the site investigator, would hinder study participation (including herbal remedies), as described in the Investigator's Brochure (IB) or listed in the Study Specific Procedures (SSP), and/ or Protocol Section 4.4

• Known history of clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease

• Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections

• Tattoo or other dermatological condition overlying the buttock region that may interfere with interpretation of injection site reactions

• Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy)

• Known history of clinically significant bleeding

• Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases

• A history of seizure disorder, per self-report

• Medical, social, or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or the safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)

• Plans to move out of the geographic area within the next 18 months or otherwise unable to participate in study visits, according to the site investigator.