Gammora® combined with antiretroviral treatment for HIV

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

This study is testing if adding a new treatment called Gammora® to standard HIV medication helps people with HIV reduce the virus in their body and improve their immune response.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Male
• Sponsor: Federal University of São Paulo (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06799650 on ClinicalTrials.gov

What this trial studies

This phase II, open-label, randomized, controlled clinical trial evaluates the effectiveness of Gammora®, a 16-mer HIV integrase-derived peptide, in combination with a boosted darunavir antiretroviral regimen compared to the regimen alone. The study aims to determine if the addition of Gammora® leads to a more significant reduction in proviral HIV-1 DNA and an increase in apoptosis markers in CD4+ T cells among antiretroviral naïve individuals living with HIV. Participants will be randomized to receive either the Gammora® treatment or the control regimen, with a focus on measuring changes in HIV reservoirs and immune response. The trial will involve forty participants with specific eligibility criteria related to their HIV status and health metrics.

Who should consider this trial

Good fit: Ideal candidates are antiretroviral naïve individuals with confirmed HIV infection, a viral load greater than 1,000, and CD4+ T cell counts above 350 cells/mm3.

Not a fit: Patients with co-infections like HBV or HCV, or those with significant acute illnesses or certain medical conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to a significant reduction in the HIV reservoir, potentially moving closer to a functional cure for HIV.

How similar studies have performed: While the approach of using integrase-derived peptides is innovative, similar studies have shown promise in targeting HIV reservoirs, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Rdss — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Ricardo S Diaz, M.D., Ph.D. — Universidade Federal de São Paulo,
• Study coordinator: Ricardo S Diaz, M.D.; Ph.D.

Conditions HIV Seropositivity; HIV cure; integrase peptide; proviral HIV DNA; apoptosis; antiretroviral therapy