Phase 2 Completed N=9 Prevention

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

Source: ClinicalTrials.gov NCT04692077 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Jan 2025

Primary outcomePrimary: Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA. — 8 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA.	8	—
PRIMARY Tolerability Endpoint: Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections Due to Intolerability of Injection, Frequency of Injections or Burden of Study Procedures.	9; 5; 3; 1; 8	—
PRIMARY Acceptability Endpoint: Proportion of Participants Who Complete All Scheduled Injections and Proportion of Participants Who Receive at Least One Injection Whom Would Consider Using CAB LA for HIV Prevention in the Future.	9; 6; 4; 0; 1; 0	—
SECONDARY Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90)	1; 0; 0; 8; 0; 1	—
SECONDARY Measure Study Product Concentrations in Enrolled Participants With HPTN Laboratory Center (LC) Confirmed HIV Infection Throughout Study.	—	—
SECONDARY Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection Phases	3; 8	—
SECONDARY Proportion of Participants Receiving One or More Injections Who Experience Grade 2 or Higher Clinical AEs and Laboratory Abnormalities From Initial Injection to 36 Weeks Later.	8	—
SECONDARY Proportion of Injection Visits That Occurred "On-time".	40; 32	—
SECONDARY Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period	1; 1; 0; 0; 0; -1	—
SECONDARY Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study	0; 0; 0	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04692077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.