HIV SeropositivityPhase 2NCT06799650
Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV
A Phase 2 study testing Gammora® in people with HIV Seropositivity, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Gammora®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2025to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- HIV Seropositivity
- Being tested
- Gammora®
- Keywords
- HIV cure, integrase peptide, proviral HIV DNA, apoptosis, antiretroviral therapy
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gammora®Drug
Also called Tenofovir, 3TC, Darunavir, Ritonavir
Gammora® SC + Tenofovir/3TC + darunavir+ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Gammora® arm | Experimental | 16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen Receives: Drug: Gammora® |
| Control arm | No intervention | Tenofovir/3TC + boosted darunavir antiretroviral regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Proviral HIV DNA quantitation
Total HIV DNA measured by qPCR
Measured: Weekly from time of randomization for 27 consecutive weeks
Episomal Proviral HIV DNA quantitation
Episomal HIV DNA measured by qPCR
Measured: 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)
Measured: Three times per week during from randomization to week 3 and weekly from that point through week 27
Secondary outcomes (5)
HIV Viral load
Viral RNA in copies per mL of plasma
Measured: Weekly from time of randomization for 27 consecutive weeks
CD4 T cell counts
CD4+ T cell count per mL
Measured: Weekly from time of randomization for 27 consecutive weeks
CD8 T cell counts
CD8+ T cell count per mL
Measured: 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
CD38 and HLA-DR in CD4 and CD8+ T cell lymphocytes by flow cytometry
Measured: Weekly for 12 weeks and every 4 weeks after that
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
A list of adverse events, separated by treatment-related or not treatment-related as assessed by CTCAE v4.0 per participant.
Measured: Weekly for 12 weeks and every 4 weeks after that
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Code Pharma
- Responsible party
- Principal investigator, Ricardo Sobhie Diaz, Federal University of São Paulo
- Investigators
- Ricardo S Diaz, M.D., Ph.D., Principal investigator, Universidade Federal de São Paulo,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799650
- Sponsor's protocol ID
- CP-22-03
- Status last verified
- May 2026
- First submitted
- 10 Jun 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data to be shared will be anonymized demographic data and outcome measure results.
Publications
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.
PubMed 20723214Levin 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.
PubMed 19127291Levin 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.
PubMed 20517955Rizza SA, Badley AD. HIV protease inhibitors impact on apoptosis. Med Chem. 2008 Jan;4(1):75-9. doi: 10.2174/157340608783331443.
PubMed 18220972
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06799650
- Acronym / sponsor ID
- CP-22-03
- Conditions
- HIV Seropositivity
- Keywords
- HIV cure, integrase peptide, proviral HIV DNA, apoptosis, antiretroviral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Code Pharma
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gammora® arm | Experimental | Drug: Gammora®16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen |
| Control arm | No intervention | –Tenofovir/3TC + boosted darunavir antiretroviral regimen |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Confirmed HIV infection;
- Antiretroviral naive;
- HIV Viral load > 1.000;
- CD4+ T cell counts >350 cells/mm3;
- Body weight > 50 Kg;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gammora®Also: Tenofovir, 3TC, Darunavir, RitonavirGammora® SC + Tenofovir/3TC + darunavir+ritonavir | Drug | Gammora® arm |
Primary outcome
Total Proviral HIV DNA quantitation
Time frame: Weekly from time of randomization for 27 consecutive weeks
Total HIV DNA measured by qPCR
Episomal Proviral HIV DNA quantitation
Time frame: Weekly from time of randomization for 27 consecutive weeks
Episomal HIV DNA measured by qPCR
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)
5 secondary outcomes
HIV Viral load
Time frame: Weekly from time of randomization for 27 consecutive weeks
CD4 T cell counts
Time frame: Weekly from time of randomization for 27 consecutive weeks
CD8 T cell counts
Time frame: 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
Time frame: Weekly for 12 weeks and every 4 weeks after that
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 20723214Levin 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.
- Background: PubMed 19127291Levin 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.
- Background: PubMed 20517955Levin 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.
- Background: PubMed 18220972Rizza SA, Badley AD. HIV protease inhibitors impact on apoptosis. Med Chem. 2008 Jan;4(1):75-9. doi: 10.2174/157340608783331443.
- Individual participant dataSharing planned: Yes. The data to be shared will be anonymized demographic data and outcome measure results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo S Diaz, M.D., Ph.D. principal investigator
Universidade Federal de São Paulo,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gammora® in people with HIV Seropositivity, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Proviral HIV DNA quantitation (time frame: Weekly from time of randomization for 27 consecutive weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06799650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.