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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorViiV Healthcare

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

564 Participants
are divided into 2 treatment groups
Group A: CAB ULA+ RPV ULAExperimental treatment 2 interventions
Group B: CAB LA+ RPV LAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm

Time frame
At Month 23
2

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
3

Percentage of participants with confirmed virologic failure (CVF)

CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.

Time frame
Up to Month 23
4

Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.

Time frame
Up to Month 23

Other outcomes

Sponsors and contacts

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