Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

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 naïve 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 naïve 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.

Timeline

Start

2025-01-01

Primary completion

2025-11-01

Completion

2026-11-01

Publications

• Background Levin A, Hayouka Z, Friedler A, Loyter A. Specific eradication of HIV-1 from infected cultured cells. AIDS Res Ther. 2010 Aug 19;7:31. doi: 10.1186/1742-6405-7-31.
• Background Levin A, Hayouka Z, Helfer M, Brack-Werner R, Friedler A, Loyter A. Peptides derived from HIV-1 integrase that bind Rev stimulate viral genome integration. PLoS One. 2009;4(1):e4155. doi: 10.1371/journal.pone.0004155. Epub 2009 Jan 7.
• Background Levin A, Hayouka Z, Helfer M, Brack-Werner R, Friedler A, Loyter A. Stimulation of the HIV-1 integrase enzymatic activity and cDNA integration by a peptide derived from the integrase protein. Biopolymers. 2010 Aug;93(8):740-51. doi: 10.1002/bip.21469.
• Background Rizza SA, Badley AD. HIV protease inhibitors impact on apoptosis. Med Chem. 2008 Jan;4(1):75-9. doi: 10.2174/157340608783331443.

Drugs

Indications