Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

Federal University of São Paulo

Status and phase

Enrolling

Phase 2

Conditions

HIV Seropositivity

Treatments

Drug: Gammora®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06799650

CP-22-03

Details and patient eligibility

About

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:

Will the proviral (total) HIV-1 DNA decrease rapidly in the Gammora® arm compared to the control arm?
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.

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

BMI < 18.5 kg/m2 at screening;
Coinfection with HBV (HBsAg +) or HCV;
Any significant acute illness within one week before the first visit.
Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening;
Active malignancy or malignancy in follow-up.
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;
Potential allergy or hypersensitivity to the components of the Gammora® formulation.
Participation in another clinical trial within 12 months before screening.
Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.