- To conduct an interventional clinical trial to determine the safety, pharmacokinetics, dosing and antiviral efficacy of up to 24 weeks of maintenance VRC01LS + 10-1074 immunotherapy in early-treated HIV-1 infected children in Botswana.
- To evaluate effects of treatment with VRC01LS and 10-1074 on the size and cellular composition of residual viral reservoirs.
- To investigate the influence of VRC01LS and 10-1074 treatment on the magnitude and quality of antiviral innate and adaptive immune responses.
Study Design: A phase I/II, multi-site clinical trial of dual treatment with two broadly neutralizing monoclonal antibodies (bNAbs), VRC01LS and 10-1074, offered to HIV-1 infected virally suppressed children. The study is comprised of four steps (Fig 1): PK Step, Step 1, Step 2, and Step 3. In the PK Step, background antiretroviral treatment (ART) is continued with either VRC01LS or 10-1074. Participants will undergo safety and PK testing for each bNAb used. In Step 1, ART is continued with dual bNAb treatment with PK confirmation of dual bNAb dosing. In Step 2, ART is withdrawn for fully suppressed children and dual bNAb maintenance treatment occurs. In Step 3, dual bNAbs will be discontinued and participants will be re-started on ART.
Study Population: HIV-infected children enrolled in the Early Infant Treatment (EIT) Study who are at least 96 weeks of life and meet entry criteria;
Study Duration:The entire study is projected to take approximately 4 years. Participants will be on study individually for a period of 56-98 weeks
Sponsor: The National Institute of Allergy and Infectious Diseases (NIAID).
Study findings not published yet.