A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515070-28-00

Acronym

221611

Enrollment

Registered

2024-12-18

Start date

2024-12-23

Completion date

Unknown

Last updated

2026-01-09

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

Conditions

HIV Infections

Brief summary

Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6

Detailed description

Time to virologic suppression (HIV-1 RNA <50 c/mL) from baseline (Day 1) through Month 6, Time to TRDF (PDVF or drug-related AE, intolerability of injections, protocol defined stopping criteria or lack of efficacy) from baseline (Day 1) through Month 6, Protocol-defined VF through Month 6, Occurrence of developing RAMs through Month 6, Occurrence of developing INSTI or NNRTI RAMs through Months 12 and 24

Interventions

DRUGREKAMBYS 900 mg prolonged-release suspension for injection

DRUGVocabria 600 mg prolonged-release suspension for injection

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6	—

Secondary

Measure	Time frame
Time to virologic suppression (HIV-1 RNA <50 c/mL) from baseline (Day 1) through Month 6, Time to TRDF (PDVF or drug-related AE, intolerability of injections, protocol defined stopping criteria or lack of efficacy) from baseline (Day 1) through Month 6, Protocol-defined VF through Month 6, Occurrence of developing RAMs through Month 6, Occurrence of developing INSTI or NNRTI RAMs through Months 12 and 24	—

Measure

Time frame

—

Countries

Belgium, Germany, Italy, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026