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Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

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)

ClinicalTrials.gov ID: NCT06741397

Public ClinicalTrials.gov record NCT06741397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 4:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of A New Formulation of Cabotegravir LA Injected Intramuscularly Q4M in Adolescent and Adult Participants at Risk of HIV Acquisition

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06741397
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
ViiV Healthcare
Industry
Enrollment
229 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 20, 2024 (Actual)
Primary completion
Sep 9, 2026 (Actual)
Completion
Aug 30, 2029 (Estimated)
Last update posted
Oct 5, 2026

2024 – 2029

United States locations

U.S. sites
25
U.S. states
15
U.S. cities
22
Facility City State ZIP Site status
GSK Investigational Site Birmingham Alabama 35222 —
GSK Investigational Site Los Angeles California 90027 —
GSK Investigational Site Los Angeles California 90035 —
GSK Investigational Site Los Angeles California 90036 —
GSK Investigational Site Los Angeles California 90069 —
GSK Investigational Site Palm Springs California 92262 —
GSK Investigational Site Doral Florida 33172-2513 —
GSK Investigational Site Ft. Pierce Florida 34982-7148 —
GSK Investigational Site Orlando Florida 32803-1851 —
GSK Investigational Site West Palm Beach Florida 33407 —
GSK Investigational Site Chicago Illinois 60612-7230 —
GSK Investigational Site New Orleans Louisiana 70112 —
GSK Investigational Site Springfield Massachusetts 01105 —
GSK Investigational Site Berkley Michigan 48072 —
GSK Investigational Site Kansas City Missouri 64111 —
GSK Investigational Site Las Vegas Nevada 89119 —
GSK Investigational Site Hawthorne New York 10532-2140 —
GSK Investigational Site New York New York 10029 —
GSK Investigational Site Greensboro North Carolina 27401-1209 —
GSK Investigational Site Cincinnati Ohio 45267 —
GSK Investigational Site Columbus Ohio 43210 —
GSK Investigational Site Pittsburgh Pennsylvania 15212 —
GSK Investigational Site Dallas Texas 75246-2004 —
GSK Investigational Site Fort Worth Texas 76104 —
GSK Investigational Site Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06741397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 5, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06741397 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →