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A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

NCT07650916 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2026-08-14

No results posted yet for this study

Summary

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Conditions

  • HIV Infections

Interventions

DRUG

CAB ULA

CAB ULA will be administered.

DRUG

RPV ULA

RPV ULA will be administered.

DRUG

CAB LA

CAB LA will be administered.

DRUG

RPV LA

RPV LA will be administered.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-25
Primary Completion
2029-09-04
Completion
2029-09-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Japan
  • Mexico
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650916 on ClinicalTrials.gov