A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed - 213500 - SOLAR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54886

Enrollment

Registered

2020-09-02

Start date

2021-01-14

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus Type-1

Interventions

IM Injections every 2 months (Oral Lead In): Day 1 - CAB 30 mg + RPV 25 mg oral, administered once daily for 1 month Month 1 - CAB LA 600 mg + RPV LA 900 mg IM, each given as 1 X 3 mL IM injection Mon

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 18 years or older - Women not pregnant, not lactating, or having a Non-reproductive potential or Postmenopausal - Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. Only a single prior INI regimen is allowed if BIK is a second line regimen > 6 months prior to screening. - Documented evidence of plasma HIV-1 RNA measurements

Exclusion criteria

Exclusion criteria: 1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement 50 c/mL 2. Within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements 50 c/mL. 3. History of prior treatment failure to any DHHS recommended ART regimen. 4. History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns 5. Any change to a second line regimen 7. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study 8. Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi*s sarcoma not requiring systemic therapy, and CD4+ counts =3 × ULN 32. Exposure to an experimental drug or experimental vaccine within either 30 days, 5

Design outcomes

Primary

Measure	Time frame
To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two months compared to a BIK single tablet regimen administered once daily: Proportion of participants with plasma HIV-RNA greater than or equal to 50 copies/mL as per Food and Drug Administration (FDA) Snapshot algorithm at Month 12 (OLI and BIK)/Month 11 (D2I) (Intent-to-Treat Exposed [ITT-E] population)	—

Secondary

Measure	Time frame
To demonstrate the antiviral and immunologic activity of CAB LA + RPV LA every 2 months compared to a BIK single tablet regimen administered once daily: Proportion of participants with plasma HIV-1 RNA	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)