A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in HIV-1-Infected Adults A Multicenter Trial of the AIDS Clinical Trials Group (ACTG)
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- STATUS
- Not Recruiting
Summary
This is an open-label, single arm study to evaluate the safety, tolerability, and virologic efficacy of the combination of CAB LA plus VRC01LS in HIV-1 infected participants with well-controlled viral replication. Seventy-four participants will be enrolled over approximately 9 to 12 months. It is hypothesized that the parenteral administration of CAB LA plus VRC01LS after a lead-in period of oral CAB plus two NRTIs will be safe and efficacious in preventing HIV-1 RNA rebound (virologic failure is defined as confirmed HIV-1 RNA greater than or equal to 200 copies/mL) up to 44 weeks after initiation of the long-acting combination. To ensure participants safety, virologic failures and AEs will be monitored regularly by the core team. An independent ACTG appointed Study Monitoring Committee (SMC) will review the interim study data
Details
| Condition | TBD |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | TBD |
| Last Modified on | 19 February 2024 |
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