A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

NCT06741397 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2192302024-000061-24
• Study Type: interventional
• Target: 229
• Locations: 2 countries
• Sites: 27

Brief Summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

Conditions

HIV Infections

Keywords

Cabotegravir (CAB); New formulation of CAB LA; CAB LA; HIV; 4-month dosing interval (Q4M); Safety

Outcome Measures

Primary Outcomes (1)

• CAB trough concentrations for target of 1.05 microgram per milliliter (μg/mL) for men and 1.39 μg/mL for women

  CAB trough concentrations are evaluated at or above the target of 1.05 μg/mL for men and 1.39 μg/mL for women, once steady state has been achieved, but no earlier than Month 13 of the study.

  From Month 13 to Month 25

Secondary Outcomes (11)

• CAB trough concentrations for target of 0.672 μg/mL for men and 0.683 μg/mL for women

  At Month 1

• CAB trough concentrations for target of 1.05 μg/mL for men and 1.39 μg/mL for women following loading dose

  From Month 3 to Month 33

• CAB plasma concentrations

  At Day 1, Day 1+1Week (W), Month (M) 1, M1+1W, M2, M3, M3+1W, M4, M5, M5+1W, M6, M7, M8, M9, M9+1W, M10, M11, M13, M13+1W, M17, M17+1W, M21, M25, M29, and M33

• CAB trough concentrations for target of 4x PA-IC90

  At Months 1, 3, 5, 9, 13, 17, 21, 25, 29, and 33

• Percentage of participants with confirmed incident HIV infections

  Up to Month 33

Study Arms (1)

CAB Group

EXPERIMENTAL

Participants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5 and every 4 months thereafter to Month 29.

Drug: CAB LA; Drug: New formulation of CAB LA

Interventions

CAB LA DRUG

Injections administered IM gluteal.

CAB Group

New formulation of CAB LA DRUG

Injections administered IM gluteal.

CAB Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg.
• Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid test, nonrapid HIV immunoassay, and HIV RNA).
• Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months.
• Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening.
• No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
• Participants who have received oral PrEP are eligible, but they must discontinue oral PrEP within 10 days of Day 1 visit.
• Male or female at birth, (transgender individuals are not excluded). Contraceptive use should align with local regulations. Participants assigned female at birth must not be pregnant or breastfeeding and must either not be of childbearing potential (POCBP) or use highly effective contraception. A POCBP must have a negative pregnancy test within 30 days before dosing.
• Participants must be \>=16 years old, of legal age to consent to sexual intercourse, and capable of giving written informed consent. Adolescents must provide written informed assent/consent and/or obtain parental/guardian consent if not of legal age, as per site SOPs and IRB/EC policies.

You may not qualify if:

• One or more reactive or positive HIV test results at Screening or Enrollment, even if HIV infection was not confirmed.
• Participants who are breastfeeding or plan to become pregnant or breastfeed during the study.
• Alanine aminotransferase (ALT) \>=3 times the upper limit of normal (ULN).
• Evidence of active Hepatitis B virus (HBV) infection.
• Participants positive for HBsAg or HBV DNA are excluded.
• Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
• Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• History of clinically relevant hepatitis within last 6 months.
• Known history of liver cirrhosis with or without viral hepatitis co-infection.
• Participants with Hepatitis C virus (HCV) co-infection will be allowed entry into this study if:
• Liver enzymes meet entry criteria.
• HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the primary endpoint (e.g., Month 13).
• In the event that recent biopsy or imaging data is not available or inconclusive, the Fibrosis 4 (Fib-4) score will be used to verify eligibility:
• Estimated glomerular filtration rate of \<30 mL/min/1.73 m\^2 via CKD-EPIcr\_R (2021) method.
• Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (27)

GSK Investigational Site

Birmingham, Alabama, 35222, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90035, United States

Location

GSK Investigational Site

Los Angeles, California, 90036, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

Location

GSK Investigational Site

Doral, Florida, 33172, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33407, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612-7230, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70112, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01105, United States

Location

GSK Investigational Site

Berkley, Michigan, 48072, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89119, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

Valhalla, New York, 10595, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27401-1209, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45267, United States

Location

GSK Investigational Site

Columbus, Ohio, 43210, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15212, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

San Juan, 00909, Puerto Rico

Location

GSK Investigational Site

San Juan, 909, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 19, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): January 10, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (25); PR (2)