Actively Recruiting
Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV
Led by Federal University of São Paulo · Updated on 2025-08-08
40
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
F
Federal University of São Paulo
Lead Sponsor
C
Code Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is 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: 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.
CONDITIONS
Official Title
Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV infection
- Antiretroviral naive
- HIV viral load greater than 1,000
- CD4+ T cell counts greater than 350 cells/mm3
- Body weight greater than 50 Kg
- Signed informed consent form
You will not qualify if you...
- Body mass index less than 18.5 kg/m2 at screening
- Coinfection with hepatitis B virus or hepatitis C virus
- Significant acute illness within one week before the first visit
- Use of immunomodulatory therapy, systemic steroids, or chemotherapy within four weeks before screening
- Active malignancy or under malignancy follow-up
- Abnormal safety test results: neutrophil count less than 1,000 u/L; hemoglobin less than 9.0 gm/dl; platelet count less than 75,000 u/L; creatinine greater than 1.5 mg/dl; direct bilirubin greater than 85 bcmol/L; AST or ALT greater than 2.5 times upper normal limit
- Potential allergy or hypersensitivity to Gammora4 components
- Participation in another clinical trial within 12 months before screening
- Any medical condition making participation unsafe or unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
RDSS
São Paulo, São Paulo, Brazil, 04039-032
Actively Recruiting
Research Team
R
Ricardo S Diaz, M.D.; Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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