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Recruiting NCT07650916

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

Phase III Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAB ULA, RPV ULA, CAB LA, RPV LA.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Canada, Japan +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART

Overview

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).

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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm [Time frame: At Month 23]
  • Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm [Time frame: At Month 11 and Month 23]
  • Percentage of participants with confirmed virologic failure (CVF) [Time frame: Up to Month 23]
  • Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5 [Time frame: Up to Month 23]
  • Number of participants with drug-related serious adverse events (SAEs) [Time frame: Up to Month 23]
  • Number of participants who discontinue treatment due to AEs or injection intolerability [Time frame: Up to Month 23]
  • Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV [Time frame: Up to Month 23]
  • Ctrough of CAB and RPV [Time frame: Up to Month 23]
  • Maximum concentrations post dose (Cmax) of CAB and RPV [Time frame: Up to Month 23]
  • Area under the curve (AUC) of CAB and RPV [Time frame: Up to Month 23]
  • Absolute value of CD4+ cell counts in participants [Time frame: Up to Month 23]
  • Change from Baseline in CD4+ cell counts in participants [Time frame: At Month 23 compared to baseline (Day 1)]

Eligibility criteria

Inclusion criteria

Patient Study Participant (PSP) Inclusion criteria:

  • Adults and adolescents with HIV-1 infection aged 12 years or older with a weight >35 kg.
  • Documented HIV-1 RNA measurements <50 copies/mL in the 12 months prior to Screening.
  • HIV-1 RNA <50 copies/mL at screening assessment.
  • Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
  • Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).

Exclusion criteria

Patient Study Participant (PSP) Exclusion criteria:

  • Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
  • Any history of receiving long-acting therapy for HIV.
  • Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
  • Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 35 centers
  • GSK Investigational Site — Phoenix
  • GSK Investigational Site — Bakersfield
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — San Diego
  • GSK Investigational Site — New Haven
  • GSK Investigational Site — Washington D.C.
  • GSK Investigational Site — DeLand
  • … and 27 more centers
Argentina · 7 centers
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Ciudad Autonoma Buenos Aires
  • GSK Investigational Site — Ciudad Autonoma Buenos Aires
  • GSK Investigational Site — Córdoba
  • GSK Investigational Site — San Miguel de Tucumán
Canada · 4 centers
  • GSK Investigational Site — Vancouver
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
  • GSK Investigational Site — Montreal
Japan · 4 centers
  • GSK Investigational Site — Aichi
  • GSK Investigational Site — Kanagawa
  • GSK Investigational Site — Osaka
  • GSK Investigational Site — Tokyo
Australia · 3 centers
  • GSK Investigational Site — Darlinghurst
  • GSK Investigational Site — Sydney
  • GSK Investigational Site — Taringa
Puerto Rico · 1 center
  • GSK Investigational Site — San Juan

Identifiers

NCT: NCT07650916 · 222794 · 2024-518511-19-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗