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

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CAB LA + RPV LA — DRUG
  Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
• 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.

Study Details

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.

Key Dates

Start date

Dec 2, 2024

Status verified

May 2026

Primary completion

Aug 19, 2026

Completion

Aug 18, 2028

Study Design

Enrollment

332 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CAB LA + RPV LA Group
  Participants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months.
• Active Comparator: Oral ART Control Group
  Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.

Primary Outcome Measure

Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART [ Time Frame: At Month 6 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (41)

Find similar trials in Birmingham, AL

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