Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

Phase 2

Recruiting

• Conditions: HIV Seropositivity
• Interventions: Drug: Gammora®

• Registration Number: NCT06799650
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-07-15
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Confirmed HIV infection;
2. Antiretroviral naive;
3. HIV Viral load > 1.000;
4. CD4+ T cell counts >350 cells/mm3;
5. Body weight > 50 Kg;
6. Signed informed consent form.

Exclusion Criteria

1. BMI < 18.5 kg/m2 at screening;
2. Coinfection with HBV (HBsAg +) or HCV;
3. Any significant acute illness within one week before the first visit.
4. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening;
5. Active malignancy or malignancy in follow-up.
6. Changes in safety tests: neutrophil count < 1,000 u/L; Hb < 9.0 gm/dl; platelet count < 75,000 u/L; creatinine > 1.5 mg/dl, direct bilirubin > 85 μmol/L, AST or ALT > 2.5 X UNL;
7. Potential allergy or hypersensitivity to the components of the Gammora® formulation.
8. Participation in another clinical trial within 12 months before screening.
9. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gammora® arm	Gammora®	16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen

Primary Outcome Measures

Name	Time	Method
Total Proviral HIV DNA quantitation	Weekly from time of randomization for 27 consecutive weeks	Total HIV DNA measured by qPCR
Episomal Proviral HIV DNA quantitation	Weekly from time of randomization for 27 consecutive weeks	Episomal HIV DNA measured by qPCR
Apoptosis markers	Three times per week during from randomization to week 3 and weekly from that point through week 27	Evaluated by flow cytometry exclusively in the CD4+ T cell gates, using the PE Annexin V Apoptosis Detection kit (BD Biosciences)

Secondary Outcome Measures

Name	Time	Method
HIV Viral load	Weekly from time of randomization for 27 consecutive weeks	Viral RNA in copies per mL of plasma
CD4 T cell counts	Weekly from time of randomization for 27 consecutive weeks	CD4+ T cell count per mL
CD8 T cell counts	Weekly from time of randomization for 27 consecutive weeks	CD8+ T cell count per mL
Levels of Lymphocyte T Cell activation markers (CD38 and HLA-DR in CD4 and CD8+ T cells) for each participant	Weekly for 12 weeks and every 4 weeks after that	CD38 and HLA-DR in CD4 and CD8+ T cell lymphocytes by flow cytometry
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Weekly for 12 weeks and every 4 weeks after that	A list of adverse events, separated by treatment-related or not treatment-related as assessed by CTCAE v4.0 per participant.

Trial Locations

Locations (1)

RDSS; 🇧🇷 Sao Paulo, SP, Brazil