Clinical Study to Evaluate the Efficacy and Safety of Gammora® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral Treatment-Naïve Participants

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Confirmed HIV infection;

• Antiretroviral naive;

• HIV Viral load \> 1.000;

• CD4+ T cell counts \>350 cells/mm3;

• Body weight \> 50 Kg;

• Signed informed consent form.

Locations
Other Locations
Brazil
RDSS
RECRUITING
São Paulo
Contact Information
Primary
Ricardo S Diaz, M.D.; Ph.D.
rsdiaz@unifesp.br
+5511991090445
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 40
Treatments
Experimental: Gammora® arm
16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen
No_intervention: Control arm
Tenofovir/3TC + boosted darunavir antiretroviral regimen
Related Therapeutic Areas
Sponsors
Leads: Federal University of São Paulo
Collaborators: Code Pharma

This content was sourced from clinicaltrials.gov

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