Clinical Trial of Gammora Plus Antiretroviral Treatment for HIV
Status:
RECRUITING
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
The goal of this phase II, open-label, randomized, controlled clinical trial is to evaluate the impact of Gammora, a 16-mer HIV integrase-derived peptide associated with a boosted darunavir antiretroviral regimen compared Gammora arm) to a boosted darunavir antiretroviral regimen only (control arm) in the estimated HIV reservoir among antiretroviral nave people living with HIV. The main questions it aims to answer are:
1. Will the proviral (total) HIV-1 DNA decrease rapidly in the Gammora arm compared to the control arm?
2. Will the apoptosis markers evaluated in the CD4+ T cell by flow cytometry increase in the Gammora arm compared to the control arm? Forty antiretroviral nave viremic people with HIV with CD4+ T cell counts \>350 cells/mL will be randomized to receive 20 mg of Gammora in 2mL SC solution plus Tenofovir/3TC and Darunavir 800mg+Ritonavir 100mg (Gammora arm) or antiretroviral only (control arm). In the Gammora arm, participants had a 2-week Gammora monotherapy lead-in period with Gammora given daily before antiretroviral treatment is started, followed by 12 weeks of antiretroviral therapy plus Gammora given every other day. The first two weeks of the trial (lead-in period for the Gammora arm) were labeled w-2 and w-1 for both groups, and blood samples were collected for both groups. w0 denotes the week ART was started in both arms.