Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06799650

Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

HIV Seropositivity Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

RDSS

São Paulo, 04039-032, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gammora®

Drug

Gammora® SC + Tenofovir/3TC + darunavir+ritonavir

Other names: Tenofovir, 3TC, Darunavir, Ritonavir

Primary outcomes

  1. Total Proviral HIV DNA quantitation

    Time frame: Weekly from time of randomization for 27 consecutive weeks

    Total HIV DNA measured by qPCR

  2. Episomal Proviral HIV DNA quantitation

    Time frame: Weekly from time of randomization for 27 consecutive weeks

    Episomal HIV DNA measured by qPCR

  3. Apoptosis markers

    Time frame: 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 outcomes

  1. HIV Viral load

    Time frame: Weekly from time of randomization for 27 consecutive weeks

    Viral RNA in copies per mL of plasma

  2. CD4 T cell counts

    Time frame: Weekly from time of randomization for 27 consecutive weeks

    CD4+ T cell count per mL

  3. CD8 T cell counts

    Time frame: Weekly from time of randomization for 27 consecutive weeks

    CD8+ T cell count per mL

  4. Levels of Lymphocyte T Cell activation markers (CD38 and HLA-DR in CD4 and CD8+ T cells) for each participant

    Time frame: Weekly for 12 weeks and every 4 weeks after that

    CD38 and HLA-DR in CD4 and CD8+ T cell lymphocytes by flow cytometry

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Code Pharma

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.