Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

NCT06799650 | Recruiting Phase 2

• 1 other identifier: CP-22-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Will the proviral (total) HIV-1 DNA decrease rapidly in the Gammora® arm compared to the control arm?
2. 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

HIV Seropositivity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Total Proviral HIV DNA quantitation

  Total HIV DNA measured by qPCR

  Weekly from time of randomization for 27 consecutive weeks

• Episomal Proviral HIV DNA quantitation

  Episomal HIV DNA measured by qPCR

  Weekly from time of randomization for 27 consecutive weeks

• Apoptosis markers

  Evaluated by flow cytometry exclusively in the CD4+ T cell gates, using the PE Annexin V Apoptosis Detection kit (BD Biosciences)

  Three times per week during from randomization to week 3 and weekly from that point through week 27

Secondary Outcomes (5)

• HIV Viral load

  Weekly from time of randomization for 27 consecutive weeks

• CD4 T cell counts

  Weekly from time of randomization for 27 consecutive weeks

• CD8 T cell counts

  Weekly from time of randomization for 27 consecutive weeks

• 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

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

  Weekly for 12 weeks and every 4 weeks after that

Study Arms (2)

Gammora® arm

EXPERIMENTAL

16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen

Drug: Gammora®

Control arm

NO INTERVENTION

Tenofovir/3TC + boosted darunavir antiretroviral regimen

Interventions

Gammora® DRUG

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

Also known as: Tenofovir, 3TC, Darunavir, Ritonavir

Gammora® arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Transgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Code Pharma: collaborator

Study Sites (1)

RDSS

São Paulo, São Paulo, 04039-032, Brazil

RECRUITING

Related Publications (4)

• Levin A, Hayouka Z, Friedler A, Loyter A. Specific eradication of HIV-1 from infected cultured cells. AIDS Res Ther. 2010 Aug 19;7:31. doi: 10.1186/1742-6405-7-31.

  PMID: 20723214 BACKGROUND

• Levin A, Hayouka Z, Helfer M, Brack-Werner R, Friedler A, Loyter A. Peptides derived from HIV-1 integrase that bind Rev stimulate viral genome integration. PLoS One. 2009;4(1):e4155. doi: 10.1371/journal.pone.0004155. Epub 2009 Jan 7.

  PMID: 19127291 BACKGROUND

• Levin A, Hayouka Z, Helfer M, Brack-Werner R, Friedler A, Loyter A. Stimulation of the HIV-1 integrase enzymatic activity and cDNA integration by a peptide derived from the integrase protein. Biopolymers. 2010 Aug;93(8):740-51. doi: 10.1002/bip.21469.

  PMID: 20517955 BACKGROUND

• Rizza SA, Badley AD. HIV protease inhibitors impact on apoptosis. Med Chem. 2008 Jan;4(1):75-9. doi: 10.2174/157340608783331443.

  PMID: 18220972 BACKGROUND

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Tenofovir; Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Thiazoles; Azoles

Study Officials

• Ricardo S Diaz, M.D., Ph.D.

  Universidade Federal de São Paulo,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo S Diaz, M.D.; Ph.D.

CONTACT

+5511991090445; rsdiaz@unifesp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: January 29, 2025
• Study Start: January 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: November 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)