Long-acting Cabotegravir + Rilpivirine for HIV
(ATLAS-2M Trial)

Recruiting in Palo Alto (17 mi)

+114 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

Eligibility Criteria

Adults with HIV-1 who have maintained a viral load under 50 copies/mL and been on stable antiretroviral therapy for at least 6 months. Participants must understand the study commitments and be likely to complete them, not be pregnant or breastfeeding, and use effective contraception if of reproductive potential. Those with certain health conditions or taking specific medications are excluded.

Inclusion Criteria

I am not pregnant, not breastfeeding, and meet the fertility criteria.

Subjects enrolled in France must be affiliated to, or a beneficiary of, a social security category

Be considered as an appropriate candidate for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.)

+7 more

Exclusion Criteria

I need long-term blood thinners, with some exceptions.

I am allergic to the study drug or similar medications.

I don't have any health issues that would affect how my body handles the study medication.

+27 more

Participant Groups

The trial is testing the effectiveness of long-acting injections of Cabotegravir plus Rilpivirine given every two months compared to every month in controlling HIV-1. It includes adults previously treated with standard care or those already receiving these drugs monthly, assessing safety over a year.

4Treatment groups

Experimental Treatment

Group I: Subjects in group 2 receiving study treatment once in 8 weeksExperimental Treatment2 Interventions

Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to receive CAB LA plus RPV LA Q8W via IM route.

Group II: Subjects in group 2 receiving study treatment once in 4 weeksExperimental Treatment2 Interventions

Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to continue CAB LA plus RPV LA Q4W administration via IM route.

Group III: Subjects in group 1 receiving study treatment once in 8 weeksExperimental Treatment4 Interventions

Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q8W via IM route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.

Group IV: Subjects in group 1 receiving study treatment once in 4 weeksExperimental Treatment4 Interventions

Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q4W via intramuscular (IM) route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.