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

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CAB ULA — DRUG
  CAB ULA will be administered.
• RPV ULA — DRUG
  RPV ULA will be administered.
• CAB LA — DRUG
  CAB LA will be administered.
• RPV LA — DRUG
  RPV LA will be administered.

Study Details

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).

Key Dates

First listed

Jun 16, 2026

Start date

Jun 25, 2026

Status verified

Jul 2026

Primary completion

Sep 4, 2029

Completion

Sep 4, 2029

Study Design

Enrollment

564 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CAB ULA+ RPV ULA
  Participants will receive CAB ULA+RPV ULA.
• Active Comparator: CAB LA+ RPV LA
  Participants will receive CAB LA+RPV LA.

Primary Outcome Measure

Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm [ Time Frame: At Month 11 ]

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 (35)

Find similar trials in Phoenix, AZ

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