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

NCT06694805 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

CAB LA + RPV LA

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

DRUG

Oral ART

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

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
2024-12-02
Primary Completion
2026-08-19
Completion
2028-07-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Germany
  • Italy
  • Portugal
  • Puerto Rico
  • Spain

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 NCT06694805 on ClinicalTrials.gov