A Study Of Long-Acting Cabotegravir Plus Vrc-Hivmab075-00-Ab (Vrc07-523Ls) To Maintain Viral Suppression In Adults Living With Hiv-1
Posted Date: Apr 28, 2020
- Investigator: Carl Fichtenbaum
- Type of Study: Drug
This is a Phase II, single arm, open-label switch study to 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. At Step 1 entry, all participants will discontinue their current HIV regimen except for nucleoside reverse transcriptase inhibitors (NRTIs), and initiate oral Cabotegravir (Integrase Inhibitor). Viral load monitoring will occur at entry and week 4 (and also at week 5 if HIV-1 RNA is 50-199 copies/mL at week 4). During Step 1, participants tolerating oral Cabotegravir plus their current two NRTIs with HIV-1 RNA <50 copies/mL at week 4, or HIV-1 RNA of 50-199 copies/mL at week 4 followed by HIV-1 RNA <50 copies/mL at week 5, will register to Step 2 and receive CAB LA every 4 weeks through week R2+44 plus VRC07-523LS every 8 weeks through week R2+40. Participants in Step 1 who are not eligible for Step 2 entry will be switched to a standard of care (SOC) regimen and followed on study every 2 weeks for a total of 4 weeks and then be taken off study.
Persons Living With Hiv That Have A Cd4 Lymphocyte Count More Than 350 Cells Cu Mm And Are Undetectable By Hiv Rna Viral Load Assay (Hiv < 50 Copies/Ml) Who Are Between 53 - 115 Kg In Weight.
Hiv, Cabotegravir, Neutralizing Antibodies To Hiv
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