Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Summary

Participation Requirements

Description

This study will assess the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia. The study will be conducted...

This study will assess the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia. The study will be conducted in three steps. At Step 1 entry, all participants will discontinue their current antiretroviral therapy (ART) regimen except for nucleoside reverse transcriptase inhibitors (NRTIs), and initiate oral CAB. During Step 1, participants tolerating oral CAB plus their current two NRTIs, and displaying viral suppression (HIV-1 RNA <50 copies/mL), will register to Step 2. At entry into Step 2, eligible participants will stop their oral CAB and NRTIs and will receive a VRC07-523LS infusion plus CAB LA injection. After entry in Step 2, participants will receive CAB LA every 4 weeks through Week R2+44 plus VRC07-523LS every 8 weeks through Week R2+40. At the last visit in Step 2 (Week R2+48), or at premature study treatment discontinuation, all participants who received any CAB LA or VRC07-523LS will enter Step 3 and switch to standard of care (SOC) oral ART for approximately 48 weeks. Participants will attend a number of study visits throughout the study. Study visits may include a physical examination, clinical assessment, pregnancy testing, and blood and urine collection. Participants will remain in the study for up to 101 weeks, including approximately 5 weeks in Step 1, 48 weeks in Step 2, followed by 48 weeks in Step 3.

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