A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2216112024-515070-28-00
• Study Type: interventional
• Target: 332
• Locations: 9 countries
• Sites: 89

Brief Summary

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Conditions

HIV Infections

Keywords

HIV Infection; Cabotegravir; Rilpivirine; Long-acting; Efficacy; Safety; Durability

Outcome Measures

Primary Outcomes (1)

• Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART

  A virologic suppression is defined by HIV-1 RNA less than (\<) 50 copies (c)/mL.

  At Month 6

Secondary Outcomes (9)

• Time to virologic suppression

  From Baseline (Day 1) up to Month 6

• Time to treatment related discontinuation (=Failure) (TRDF)

  From Baseline (Day 1) up to Month 6

• Number of participants with confirmed protocol-defined virologic failure (VF)

  From Baseline (Day 1) up to Month 6

• Number of participants with treatment-emergent resistance-associated mutations (RAMs)

  From Baseline (Day 1) up to Month 6

• Number of participants with treatment-emergent RAMs

  Up to Month 12 and Month 24

Study Arms (2)

CAB LA + RPV LA Group

EXPERIMENTAL

Participants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months.

Drug: CAB LA + RPV LA

Oral ART Control Group

ACTIVE COMPARATOR

Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.

Drug: Oral ART

Interventions

Oral ART DRUG

Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.

Oral ART Control Group

CAB LA + RPV LA DRUG

Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.

CAB LA + RPV LA Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• \. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent).
• Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
• Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\<1 log10 decrease in HIV-1 RNA or HIV-1 RNA \>200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months.
• ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs).
• Currently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.
• Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.
• Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:
• Adult participants (\>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and stated in the full study protocol.
• For adolescent participants (12 to \<18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.

You may not qualify if:

• Medical Conditions
• HIV-1 Subtype A6, if known from historical result.
• Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
• History of liver cirrhosis with or without hepatitis viral co-infection.
• Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).
• Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
• History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
• Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.
• Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
• Prior/Concomitant Therapy
• Any previous use of CAB.
• Current or anticipated need for chronic anti-coagulants.
• Use of concomitant medications which are associated with Torsades de Pointes (TdP).

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (89)

GSK Investigational Site

Birmingham, Alabama, 35222, United States

RECRUITING

GSK Investigational Site

Beverly Hills, California, 90211, United States

WITHDRAWN

GSK Investigational Site

Los Angeles, California, 90035, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90036, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90069, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

GSK Investigational Site

Denver, Colorado, 80204, United States

RECRUITING

GSK Investigational Site

New Haven, Connecticut, 06510, United States

RECRUITING

GSK Investigational Site

Newark, Delaware, 19711, United States

RECRUITING

GSK Investigational Site

Washington D.C., District of Columbia, 20017, United States

RECRUITING

GSK Investigational Site

Jacksonville, Florida, 32209, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33136, United States

RECRUITING

GSK Investigational Site

Sarasota, Florida, 34237, United States

RECRUITING

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

RECRUITING

GSK Investigational Site

Atlanta, Georgia, 30308, United States

RECRUITING

GSK Investigational Site

Decatur, Georgia, 30033, United States

RECRUITING

GSK Investigational Site

Macon, Georgia, 31201, United States

RECRUITING

GSK Investigational Site

Chicago, Illinois, 60611, United States

RECRUITING

GSK Investigational Site

Chicago, Illinois, 60613, United States

RECRUITING

GSK Investigational Site

Chicago, Illinois, 60637, United States

RECRUITING

GSK Investigational Site

Baltimore, Maryland, 21201, United States

RECRUITING

GSK Investigational Site

Baltimore, Maryland, 21287, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02115, United States

RECRUITING

GSK Investigational Site

Berkley, Michigan, 48072, United States

COMPLETED

GSK Investigational Site

Kansas City, Missouri, 64111, United States

RECRUITING

GSK Investigational Site

St Louis, Missouri, 63110, United States

RECRUITING

GSK Investigational Site

Newark, New Jersey, 07102, United States

RECRUITING

GSK Investigational Site

Hawthorne, New York, 10532, United States

RECRUITING

GSK Investigational Site

New York, New York, 10010, United States

RECRUITING

GSK Investigational Site

New York, New York, 10032, United States

RECRUITING

GSK Investigational Site

The Bronx, New York, 10467, United States

RECRUITING

GSK Investigational Site

The Bronx, New York, 10468, United States

RECRUITING

GSK Investigational Site

Greensboro, North Carolina, 27401-1209, United States

RECRUITING

GSK Investigational Site

Cincinnati, Ohio, 45267, United States

RECRUITING

GSK Investigational Site

Columbus, Ohio, 43210, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75246, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Seattle, Washington, 98104, United States

RECRUITING

GSK Investigational Site

Milwaukee, Wisconsin, 53212, United States

RECRUITING

GSK Investigational Site

Buenos Aires, 1023, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, 1427, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

RECRUITING

GSK Investigational Site

Capital Federal, C1181ACH, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Bueno, C1405CKC, Argentina

RECRUITING

GSK Investigational Site

Córdoba, X5000JJS, Argentina

RECRUITING

GSK Investigational Site

Rosario, S2000PBJ, Argentina

RECRUITING

GSK Investigational Site

Antwerp, 2000, Belgium

RECRUITING

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

WITHDRAWN

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

COMPLETED

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50674, Germany

RECRUITING

GSK Investigational Site

Berlin, 10439, Germany

RECRUITING

GSK Investigational Site

Cologne, 50668, Germany

RECRUITING

GSK Investigational Site

Düsseldorf, 40225, Germany

RECRUITING

GSK Investigational Site

Frankfurt, 60596, Germany

RECRUITING

GSK Investigational Site

Bari, Italy

RECRUITING

GSK Investigational Site

Bergamo, 24127, Italy

RECRUITING

GSK Investigational Site

Milan, 20127, Italy

RECRUITING

GSK Investigational Site

Milan, 20142, Italy

RECRUITING

GSK Investigational Site

Roma, 00149, Italy

RECRUITING

GSK Investigational Site

Porto, 4099-001, Portugal

RECRUITING

GSK Investigational Site

Porto, 4200-319, Portugal

RECRUITING

GSK Investigational Site

San Juan, 00909, Puerto Rico

WITHDRAWN

GSK Investigational Site

Barcelona, 08026, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08036, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08907, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8017, Spain

RECRUITING

GSK Investigational Site

Bilbao, 48013, Spain

RECRUITING

GSK Investigational Site

Cadiz, 11510, Spain

RECRUITING

GSK Investigational Site

Córdoba, 14004, Spain

RECRUITING

GSK Investigational Site

Madrid, 28006, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28020, Spain

RECRUITING

GSK Investigational Site

Madrid, 28031, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28040, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Madrid, 28046, Spain

RECRUITING

GSK Investigational Site

Málaga, 29010, Spain

COMPLETED

GSK Investigational Site

Málaga, 29530, Spain

RECRUITING

GSK Investigational Site

Murcia, 30120, Spain

RECRUITING

GSK Investigational Site

Palma de Mallorca, 07120, Spain

RECRUITING

GSK Investigational Site

Sabadell Barcelona, 08208, Spain

RECRUITING

GSK Investigational Site

Seville, 41013, Spain

RECRUITING

GSK Investigational Site

Vigo Pontevedra, 36312, Spain

RECRUITING

GSK Investigational Site

Zaragoza, 50009, Spain

RECRUITING

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

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): July 19, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

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

AR (7); DE (5); PT (2); BE (1); CA (3); ES (24); IT (5); US (41); PR (1)