HivPhase 2NCT06805656
Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals
A Phase 2 study testing Maraviroc, Dolutegravir and Dendritic Cell Vaccine in people with Hiv and HIV I Infection, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hiv, HIV I Infection
- What is being tested?
- Maraviroc, Dolutegravir and Dendritic Cell Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2026to 1 Jun 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old < 65 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening.
- HIV viral load <50 copies/mL, and never > 50 copies/mL on 2 consecutive occasions in the last 2 years. CD4 count nadir.
- > 350 cells/ mm3 Current CD4 count > 500 cells/ mm3. R5 HIV-1 at Screening as defined by proviral DNA genotropism.
Who cannot join
- Any evidence of an active AIDS-defining condition. Any significant acute medical illness in the past 8 weeks. Women who are pregnant or breastfeeding. Use of any of the following within 90 days prior to entry: systemic cytotoxic chemotherapy; investigational agents; immunomodulators (colonystimulating factors, growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons); coumadin, warfarin, or other coumadin derivative anticoagulants. Use of an agent definitely or possibly associated with effects on QT intervals: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
- Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid or nicotinamide within the last 30 days. Potential participants may enroll after a 30-day washout period.
- Known hypersensitivity to the components of gold salt, nicotinamide or its analogs.
- Hepatitis B (HBsAg +) or Hepatitis C (HCV RNA +) infection. Known renal insufficiency defined as calculated creatinine clearance (Cockcroft Gault formula) <60 mL/min.
- Subjects with a laboratory abnormality grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglyceride, gamma glutamyl transpeptidase, bilirubin.
- Any condition which, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
CCDI
São Paulo, São Paulo
Ricardo S Diaz, M.D.; /PhD, 55-11-5576-4834, rsdiaz@unifesp.br
About this study
Official title: Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals
A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patients to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.
- Conditions
- Hiv, HIV I Infection
- Being tested
- Maraviroc, Dolutegravir, Dendritic Cell Vaccine, Auranofin, Sirtuin Histone deacetylase inhibitor
- Keywords
- Dendritic Cell vaccination, antiretroviral intensification, Auranofin, Histone Deacetylase Inhibitor, residual viral replication, HIV sanctuaries, HIV latency
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Selzentry, Celsentri
antiretroviral intensification
DolutegravirDrug
Also called Tivicay
antiretroviral intensification
Dendritic Cell VaccineBiological
Also called DC Vaccine
therapeutic vaccination
AuranofinDrug
Also called Gold Salt
purging
Sirtuin Histone deacetylase inhibitorDrug
Also called Nicotinamide
latency disruption
| Study group | Role | What they receive |
|---|---|---|
| Antiretroviral Treated (ART) Group | No intervention | Ten patients will receive no further intervention (control group) |
| ART Intensification Group | Experimental | Sixty patients will be included in this stage to undergo antiretroviral intensification with dolutegravir, the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks, gold salt (auranofin) for the last 24 weeks and dendritic cell vaccine, with the adjustment to use also maraviroc during the first 48 weeks. Receives: Drug: Maraviroc; Drug: Dolutegravir; Biological: Dendritic Cell Vaccine; Drug: Auranofin; Drug: Sirtuin Histone deacetylase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of viral load of HIV RNA over the time frame of study
Viral load count by qPCR at each time point to measure the viral persistence in each participant
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of total DNA and episomal HIV in PBMCs
Quantification of total DNA and episomal HIV in a virological assay
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of cell-associated HIV RNA in PBMCs over the study time frame
Quantification of HIV RNA in PBMCs by qPCR
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of total DNA and episomal HIV DNA in lymphoid tissue (rectal biopsy)
Quantification by in-house virological assay
Measured: baseline, week 48, after resurgence of viremia in the analytical interruption of antiretrovirals, or after 24 and 96 weeks after analytical interruption of antiretrovirals.
Evolution of the HIV DNA sequence of the V3 region of gp 120, protease, reverse transcriptase and integrase regions of the pol gene, and of the gag gene
NGS sequencing of the V3 region of gp120, the protease, reverse transcriptase, and integrase regions of the pol gene, and of the gag gene of HIV DNA
Measured: baseline, week 24, week 48, after resurgence of viremia after ATI and before reintroduction of ART
Evolution of the HIV RNA sequence of the V3 region of gp 120, protease, reverse transcriptase and integrase regions of the pol gene, and of the gag gene
NGS sequencing of the V3 region of gp120, the protease, reverse transcriptase, and integrase regions of the pol gene, and of the gag gene of HIV RNA
Measured: baseline, week 24, week 48, after resurgence of viremia after ATI and before reintroduction of ART
Evolution of CD4 + and CD8 + T lymphocyte count
Count by flow cytometry of CD4+ and CD8+ lymphocytes
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to a total of 36 months after ATI.
Evolution of percentages of CD38 and HLA DR in CD4 + and CD8 + T lymphocytes
Measurement by flow cytometry of cell activation of CD4+ and CD8+ T lymphocytes as a means of assessing immune and inflammatory responses
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of plasma cytokines IL-2, IL-4, IL-6, IL-10, IL-17, TNF and IFN-γ
Measurement by ELISA Assay of plasma cytokines IL-2, IL-4, IL-6, IL-10, IL-17, TNF and IFN-γ as a means of assessing immune and inflammatory responses
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Changes in bacterial translocation levels by quantification of plasma LPS levels
Assay for determining the proinflammatory level of endotoxin (LPS)
Measured: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Weill Medical College of Cornell University, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ricardo Sobhie Diaz, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805656
- Sponsor's protocol ID
- SPARC-11
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the range of personal data gathered, IPD will be shared on request when properly anonymized.
Publications
de Almeida Baptista MV, da Silva LT, Samer S, Oshiro TM, Shytaj IL, Giron LB, Pena NM, Cruz N, Gosuen GC, Ferreira PRA, Cunha-Neto E, Galinskas J, Dias D, Sucupira MCA, de Almeida-Neto C, Salomao R, da Silva Duarte AJ, Janini LM, Hunter JR, Savarino A, Juliano MA, Diaz RS. Immunogenicity of personalized dendritic-cell therapy in HIV-1 infected individuals under suppressive antiretroviral treatment: interim analysis from a phase II clinical trial. AIDS Res Ther. 2022 Jan 12;19(1):2. doi: 10.1186/s12981-021-00426-z.
PubMed 35022035Ndhlovu LC, Giron LB, Galinskas J, Premeaux TA, Pang APS, Dias D, de Almeida Baptista MV, Shytaj IL, Maricato JT, Ferreira PRA, Gosuen G, Corley MJ, Friday CM, Bowler SA, Della Libera E, Sucupira MC, Hunter JR, Janini LM, Schechter M, Savarino A, Diaz RS; SPARC Working Group. Virological and Immunological Outcomes of Combined Therapeutic Interventions and Dendritic Cell Therapy in People With HIV. J Infect Dis. 2025 Nov 14;232(5):1067-1077. doi: 10.1093/infdis/jiaf430.
PubMed 40810569
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals
- ClinicalTrials.gov ID
- NCT06805656
- Acronym / sponsor ID
- SPARC-11
- Conditions
- Hiv, HIV I Infection
- Keywords
- Dendritic Cell vaccination, antiretroviral intensification, Auranofin, Histone Deacetylase Inhibitor, residual viral replication, HIV sanctuaries, HIV latency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Weill Medical College of Cornell University, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Feb 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.
A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patients to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiretroviral Treated (ART) Group | No intervention | –Ten patients will receive no further intervention (control group) |
| ART Intensification Group | Experimental | Drug: Maraviroc, Drug: Dolutegravir, Biological: Dendritic Cell Vaccine, Drug: Auranofin, Drug: Sirtuin Histone deacetylase inhibitorSixty patients will be included in this stage to undergo antiretroviral intensification with dolutegravir, the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks, gold salt (auranofin) for the last 24 weeks and dendritic cell vaccine, with the adjustment to use also maraviroc during the first 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old < 65 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening.
- HIV viral load <50 copies/mL, and never > 50 copies/mL on 2 consecutive occasions in the last 2 years. CD4 count nadir.
- > 350 cells/ mm3 Current CD4 count > 500 cells/ mm3. R5 HIV-1 at Screening as defined by proviral DNA genotropism.
Key exclusion criteria (6 listed)
- Any evidence of an active AIDS-defining condition. Any significant acute medical illness in the past 8 weeks. Women who are pregnant or breastfeeding. Use of any of the following within 90 days prior to entry: systemic cytotoxic chemotherapy; investigational agents; immunomodulators (colonystimulating factors, growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons); coumadin, warfarin, or other coumadin derivative anticoagulants. Use of an agent definitely or possibly associated with effects on QT intervals: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
- Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid or nicotinamide within the last 30 days. Potential participants may enroll after a 30-day washout period.
- Known hypersensitivity to the components of gold salt, nicotinamide or its analogs.
- Hepatitis B (HBsAg +) or Hepatitis C (HCV RNA +) infection. Known renal insufficiency defined as calculated creatinine clearance (Cockcroft Gault formula) <60 mL/min.
- Subjects with a laboratory abnormality grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglyceride, gamma glutamyl transpeptidase, bilirubin.
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 |
|---|---|---|
| MaravirocAlso: Selzentry, Celsentriantiretroviral intensification | Drug | ART Intensification Group |
| DolutegravirAlso: Tivicayantiretroviral intensification | Drug | ART Intensification Group |
| Dendritic Cell VaccineAlso: DC Vaccinetherapeutic vaccination | Biological | ART Intensification Group |
| AuranofinAlso: Gold Saltpurging | Drug | ART Intensification Group |
| Sirtuin Histone deacetylase inhibitorAlso: Nicotinamidelatency disruption | Drug | ART Intensification Group |
Primary outcome
Evolution of viral load of HIV RNA over the time frame of study
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Viral load count by qPCR at each time point to measure the viral persistence in each participant
Evolution of total DNA and episomal HIV in PBMCs
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Quantification of total DNA and episomal HIV in a virological assay
Evolution of cell-associated HIV RNA in PBMCs over the study time frame
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Quantification of HIV RNA in PBMCs by qPCR
Evolution of total DNA and episomal HIV DNA in lymphoid tissue (rectal biopsy)
Time frame: baseline, week 48, after resurgence of viremia in the analytical interruption of antiretrovirals, or after 24 and 96 weeks after analytical interruption of antiretrovirals.
Quantification by in-house virological assay
Evolution of the HIV DNA sequence of the V3 region of gp 120, protease, reverse transcriptase and integrase regions of the pol gene, and of the gag gene
Time frame: baseline, week 24, week 48, after resurgence of viremia after ATI and before reintroduction of ART
NGS sequencing of the V3 region of gp120, the protease, reverse transcriptase, and integrase regions of the pol gene, and of the gag gene of HIV DNA
Evolution of the HIV RNA sequence of the V3 region of gp 120, protease, reverse transcriptase and integrase regions of the pol gene, and of the gag gene
Time frame: baseline, week 24, week 48, after resurgence of viremia after ATI and before reintroduction of ART
NGS sequencing of the V3 region of gp120, the protease, reverse transcriptase, and integrase regions of the pol gene, and of the gag gene of HIV RNA
Evolution of CD4 + and CD8 + T lymphocyte count
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to a total of 36 months after ATI.
Count by flow cytometry of CD4+ and CD8+ lymphocytes
Evolution of percentages of CD38 and HLA DR in CD4 + and CD8 + T lymphocytes
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Measurement by flow cytometry of cell activation of CD4+ and CD8+ T lymphocytes as a means of assessing immune and inflammatory responses
Evolution of plasma cytokines IL-2, IL-4, IL-6, IL-10, IL-17, TNF and IFN-γ
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Measurement by ELISA Assay of plasma cytokines IL-2, IL-4, IL-6, IL-10, IL-17, TNF and IFN-γ as a means of assessing immune and inflammatory responses
Changes in bacterial translocation levels by quantification of plasma LPS levels
Time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Assay for determining the proinflammatory level of endotoxin (LPS)
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 19 Aug 2026.
- Background: PubMed 35022035de Almeida Baptista MV, da Silva LT, Samer S, Oshiro TM, Shytaj IL, Giron LB, Pena NM, Cruz N, Gosuen GC, Ferreira PRA, Cunha-Neto E, Galinskas J, Dias D, Sucupira MCA, de Almeida-Neto C, Salomao R, da Silva Duarte AJ, Janini LM, Hunter JR, Savarino A, Juliano MA, Diaz RS. Immunogenicity of personalized dendritic-cell therapy in HIV-1 infected individuals under suppressive antiretroviral treatment: interim analysis from a phase II clinical trial. AIDS Res Ther. 2022 Jan 12;19(1):2. doi: 10.1186/s12981-021-00426-z.
- Background: PubMed 40810569Ndhlovu LC, Giron LB, Galinskas J, Premeaux TA, Pang APS, Dias D, de Almeida Baptista MV, Shytaj IL, Maricato JT, Ferreira PRA, Gosuen G, Corley MJ, Friday CM, Bowler SA, Della Libera E, Sucupira MC, Hunter JR, Janini LM, Schechter M, Savarino A, Diaz RS; SPARC Working Group. Virological and Immunological Outcomes of Combined Therapeutic Interventions and Dendritic Cell Therapy in People With HIV. J Infect Dis. 2025 Nov 14;232(5):1067-1077. doi: 10.1093/infdis/jiaf430.
- Individual participant dataSharing planned: No. Because of the range of personal data gathered, IPD will be shared on request when properly anonymized.
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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.
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 Maraviroc, Dolutegravir and Dendritic Cell Vaccine in people with Hiv and HIV I Infection, 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
Contact Ricardo S Diaz, M.D.; PhD (+55 11 991090445, rsdiaz@catg.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of viral load of HIV RNA over the time frame of study (time frame: baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI). The study lists 10 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 NCT06805656, which also lists 2 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 19 Aug 2026.