HIVPhase 2Codivir®NCT06676410
Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
A Phase 2 study testing ICF, Eligibility Assessment and Demographic data in people with HIV and HIV Infection, run by Code Pharma at 1 site in Brazil.
Trial summary
The study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infection
- What is being tested?
- ICF, Eligibility Assessment and Demographic data
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2023to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female sex;
- Age ≥ 18 years;
- HIV infection confirmed by serology (Ab for HIV1/HIV2) and HIV1/HIV2 RNA test;
- Naive for antiretroviral treatment;
- Viral load \> 1,000 and \< 50,000 copies/mL;
- CD4 T lymphocyte (CD4) cell count \>350 cells/mm3;
- Body weight at V -1 \> 50 Kg;
- Signature of the ICF.
Who cannot join
- Pregnancy, lactation or plan to become pregnant;
- BMI \< 18.5 kg/m2 at screening;
- Coinfection with HBV (HBSAg +) or HCV;
- Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)* rating scale;
- Any significant acute illness within 1 week before V0.
- Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening;
Show all 11Show fewer
- Active malignancy or ongoing malignancy;
- Changes in safety tests: neutrophil count \< 1000 u/L; Hb \< 9.0 gm/dl; platelet \< 75,000 u/L; creatinine \> 1.5 mg/dl, direct bilirubin \> 85 μmol/l, AST or ALT \> 2.5 X ULN;
- Potential allergy or hypersensitivity to components of the Codivir® formulation.
- Participation in another clinical trial within 12 months of screening.
- Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.
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
RDSS Research Center
São Paulo, 04037-030
Siderleny Martins, +55 19 98911-9721, martins@a2zclinical.com.br
About this study
The study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step.
At V0 (W0, D0) all participants will start the antiretroviral treatment described above.
Read more
From V0 (W0, D0) to V6 (W12, D84) participants randomized to Codivir® will receive Codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day).
At V6 (W12, D84) treatment with Codivir® will end. At V7 (W24, D168) participation in the study will end. Viral load will be monitored during the study. In case of failure, participation in the study will be discontinued and the participant will be referred to receive the best treatment available for their case.
- Conditions
- HIV, HIV Infection
- Being tested
- ICF, Eligibility Assessment, Demographic data, Weight, height and BMI, Vital Signs
- Keywords
- HIV, AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICFOther
Application of Informed Consent Form.
Eligibility AssessmentBehavioural
Assessment of inclusion, exclusion and discontinuation criteria.
Demographic dataOther
Collection of demographic data.
Weight, height and BMIDiagnostic test
Weight and height measurement and body mass index calculation.
Vital SignsOther
HR, BP and FR and T°, in addition to oximetry.
Medical evaluationDiagnostic test
Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
Safety examDiagnostic test
Blood collection for safety laboratory exams. Blood count, Na, K, U, C, amylase, total cholesterol and fractions, triglycerides, coagulation tests (TTTP, TT, platelets), TGO, TGP, AP, GGT, glycated hemoglobin, total bilirubin and fractions, creatine kinase and CKmB and urine I.
Pregnancy testDiagnostic test
β-HCG in urine in non-sterile women
SerologyDiagnostic test
HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
RandomizationOther
Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group
Apoptosis markersDiagnostic test
Caspases and Annexin V.
Cell activation markersDiagnostic test
PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR
Inflammation markersDiagnostic test
ultrasensitive CRP, D-dimer.
Proviral DNA:Diagnostic test
Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.
HIV-specific antibodiesDiagnostic test
Anti-HIV-1 specific antibody titers in plasma.
HIV viral load (RNA)Diagnostic test
Performed on plasma.
Codivir® TrainingBehavioural
The participant is trained to self-inject Codivir®
Dispensing Codivir®Drug
the participant receives Codivir®
Codivir® AccountingOther
The Codivir® used since the last visit is accounted for
Concomitant medicationOther
Record of concomitant medications used.
Adverse eventsOther
Collection and recording of adverse events.
AntiretroviralsDrug
Tenofovir - inhibits HIV-1 reverse transcriptase activity by competing with the natural substrate, deoxyadenosine 5'-triphosphate and, upon incorporation into DNA, causes DNA chain termination.
- Lamivudine - potent selective inhibitor of HIV-1 and HIV-2 replication in vitro.
- Darunavir - prevents the formation of mature infective viral particles, indicated for the treatment of the human immunodeficiency virus (HIV), which causes AIDS.
- Ritonavir: antiretroviral protease inhibitor, widely used in combination with other protease inhibitors in the therapy and prevention of HIV infection, which causes the syndrome acquired immunodeficiency (AIDS).
- Single solid formulation (in 1 tablet) 1x/day with:
- Tenofovir (TDF) 300 mg
- Lamivudine (3TC) 300 mg
- Darunavir (DRV) 800 mg, 1x/day
- Ritonavir (RTV) 100 mg, 1x/day
| Study group | Role | What they receive |
|---|---|---|
| Codivir® | Experimental | The study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step.
In Weeks 0-24, all participants will receive:
* Single solid formulation (in 1 tablet) 1x/day with:
* Tenofovir (TDF) 300 mg
* Lamivudine (3TC) 300 mg
* Darunavir (DRV) 800 mg, 1x/day
* Ritonavir (RTV) 100 mg, 1x/day From V0 (W0, D0) to V6 (W12, D84) participants randomized to Codivir® will receive Codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day).
At V6 (week 12) treatment with Codivir® will end. Receives: Other: ICF; Behavioral: Eligibility Assessment; Other: Demographic data; Diagnostic Test: Weight, height and BMI; Other: Vital Signs; Diagnostic Test: Medical evaluation; Diagnostic Test: Safety exam; Diagnostic Test: Pregnancy test; Diagnostic Test: Serology; Other: Randomization; Diagnostic Test: Apoptosis markers; Diagnostic Test: Cell activation markers; Diagnostic Test: Inflammation markers; Diagnostic Test: Proviral DNA:; Diagnostic Test: HIV-specific antibodies; Diagnostic Test: HIV viral load (RNA); Behavioral: Codivir® Training; Drug: Dispensing Codivir®; Other: Codivir® Accounting; Other: Concomitant medication; Other: Adverse events |
| Antiretrovirals (ARTs) | Active comparator | In Weeks 0-24, all participants will receive:
* Single solid formulation (in 1 tablet) 1x/day with:
* Tenofovir (TDF) 300 mg
* Lamivudine (3TC) 300 mg
* Darunavir (DRV) 800 mg, 1x/day
* Ritonavir (RTV) 100 mg, 1x/day Receives: Other: ICF; Behavioral: Eligibility Assessment; Other: Demographic data; Diagnostic Test: Weight, height and BMI; Other: Vital Signs; Diagnostic Test: Medical evaluation; Diagnostic Test: Safety exam; Diagnostic Test: Pregnancy test; Diagnostic Test: Serology; Other: Randomization; Diagnostic Test: Apoptosis markers; Diagnostic Test: Cell activation markers; Diagnostic Test: Inflammation markers; Diagnostic Test: Proviral DNA:; Diagnostic Test: HIV-specific antibodies; Diagnostic Test: HIV viral load (RNA); Other: Concomitant medication; Other: Adverse events; Drug: Antiretrovirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA.
Measured: 12 weeks
Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count
Measured: 12 weeks
Secondary outcomes (9)
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count.
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA)
Measured: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA)
Measured: 24 weeks
- Comparison of viral load curves from all visits between the two groups.
Measured: 24 weeks
Codivir® safety by comparison of treatment-emergent adverse events in both groups.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start20 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomization Forty participants with a recent diagnosis of HIV infection, without previous antiretroviral treatment and indication to start antiretroviral treatment, will be randomized as follows: * 20 participants will receive Standard Antiretroviral Treatment + Codivir * 20 participants will only receive Standard Antiretroviral Treatment A randomization will be balanced by sex and age.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Code Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Galilee CBR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676410
- Sponsor's protocol ID
- CP-22-03
- Acronym
- Codivir®
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
- ClinicalTrials.gov ID
- NCT06676410
- Acronym / sponsor ID
- Codivir® / CP-22-03
- Conditions
- HIV, HIV Infection
- Keywords
- HIV, AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Code PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Galilee CBR
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2024 (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 study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step.
At V0 (W0, D0) all participants will start the antiretroviral treatment described above.
From V0 (W0, D0) to V6 (W12, D84) participants randomized to Codivir® will receive Codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day).
At V6 (W12, D84) treatment with Codivir® will end. At V7 (W24, D168) participation in the study will end. Viral load will be monitored during the study. In case of failure, participation in the study will be discontinued and the participant will be referred to receive the best treatment available for their case.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization Forty participants with a recent diagnosis of HIV infection, without previous antiretroviral treatment and indication to start antiretroviral treatment, will be randomized as follows: * 20 participants will receive Standard Antiretroviral Treatment + Codivir * 20 participants will only receive Standard Antiretroviral Treatment A randomization will be balanced by sex and age.
| Arm | Type | Receives |
|---|---|---|
| Codivir® | Experimental | Other: ICF, Behavioral: Eligibility Assessment, Other: Demographic data, Diagnostic Test: Weight, height and BMI, Other: Vital Signs, Diagnostic Test: Medical evaluation, Diagnostic Test: Safety exam, Diagnostic Test: Pregnancy test, Diagnostic Test: Serology, Other: Randomization, Diagnostic Test: Apoptosis markers, Diagnostic Test: Cell activation markers, Diagnostic Test: Inflammation markers, Diagnostic Test: Proviral DNA:, Diagnostic Test: HIV-specific antibodies, Diagnostic Test: HIV viral load (RNA), Behavioral: Codivir® Training, Drug: Dispensing Codivir®, Other: Codivir® Accounting, Other: Concomitant medication, Other: Adverse eventsThe study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step. In Weeks 0-24, all participants will receive: * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day From V0 (W0, D0) to V6 (W12, D84) participants randomized to Codivir® will receive Codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day). At V6 (week 12) treatment with Codivir® will end. |
| Antiretrovirals (ARTs) | Active comparator | Other: ICF, Behavioral: Eligibility Assessment, Other: Demographic data, Diagnostic Test: Weight, height and BMI, Other: Vital Signs, Diagnostic Test: Medical evaluation, Diagnostic Test: Safety exam, Diagnostic Test: Pregnancy test, Diagnostic Test: Serology, Other: Randomization, Diagnostic Test: Apoptosis markers, Diagnostic Test: Cell activation markers, Diagnostic Test: Inflammation markers, Diagnostic Test: Proviral DNA:, Diagnostic Test: HIV-specific antibodies, Diagnostic Test: HIV viral load (RNA), Other: Concomitant medication, Other: Adverse events, Drug: AntiretroviralsIn Weeks 0-24, all participants will receive: * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female sex;
- Age ≥ 18 years;
- HIV infection confirmed by serology (Ab for HIV1/HIV2) and HIV1/HIV2 RNA test;
- Naive for antiretroviral treatment;
- Viral load \> 1,000 and \< 50,000 copies/mL;
Key exclusion criteria (11 listed)
- Pregnancy, lactation or plan to become pregnant;
- BMI \< 18.5 kg/m2 at screening;
- Coinfection with HBV (HBSAg +) or HCV;
- Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)* rating scale;
- Any significant acute illness within 1 week before V0.
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 |
|---|---|---|
| ICFApplication of Informed Consent Form. | Other | Antiretrovirals (ARTs), Codivir® |
| Eligibility AssessmentAssessment of inclusion, exclusion and discontinuation criteria. | Behavioural | Antiretrovirals (ARTs), Codivir® |
| Demographic dataCollection of demographic data. | Other | Antiretrovirals (ARTs), Codivir® |
| Weight, height and BMIWeight and height measurement and body mass index calculation. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Vital SignsHR, BP and FR and T°, in addition to oximetry. | Other | Antiretrovirals (ARTs), Codivir® |
| Medical evaluationMedical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Safety examBlood collection for safety laboratory exams. Blood count, Na, K, U, C, amylase, total cholesterol and fractions, triglycerides, coagulation tests (TTTP, TT, platelets), TGO, TGP, AP, GGT, glycated hemoglobin, total bilirubin and fractions, creatine kinase and CKmB and urine I. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Pregnancy testβ-HCG in urine in non-sterile women | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| SerologyHBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab). | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| RandomizationAssignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group | Other | Antiretrovirals (ARTs), Codivir® |
| Apoptosis markersCaspases and Annexin V. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Cell activation markersPBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Inflammation markersultrasensitive CRP, D-dimer. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Proviral DNA:Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| HIV-specific antibodiesAnti-HIV-1 specific antibody titers in plasma. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| HIV viral load (RNA)Performed on plasma. | Diagnostic test | Antiretrovirals (ARTs), Codivir® |
| Codivir® TrainingThe participant is trained to self-inject Codivir® | Behavioural | Codivir® |
| Dispensing Codivir®the participant receives Codivir® | Drug | Codivir® |
| Codivir® AccountingThe Codivir® used since the last visit is accounted for | Other | Codivir® |
| Concomitant medicationRecord of concomitant medications used. | Other | Antiretrovirals (ARTs), Codivir® |
| Adverse eventsCollection and recording of adverse events. | Other | Antiretrovirals (ARTs), Codivir® |
| AntiretroviralsTenofovir - inhibits HIV-1 reverse transcriptase activity by competing with the natural substrate, deoxyadenosine 5'-triphosphate and, upon incorporation into DNA, causes DNA chain termination. * Lamivudine - potent selective inhibitor of HIV-1 and HIV-2 replication in vitro. * Darunavir - prevents the formation of mature infective viral particles, indicated for the treatment of the human immunodeficiency virus (HIV), which causes AIDS. * Ritonavir: antiretroviral protease inhibitor, widely used in combination with other protease inhibitors in the therapy and prevention of HIV infection, which causes the syndrome acquired immunodeficiency (AIDS). * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day | Drug | Antiretrovirals (ARTs) |
Primary outcome
Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA.
Time frame: 12 weeks
Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count
Time frame: 12 weeks
9 secondary outcomes
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count.
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA)
Time frame: 24 weeks
Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA)
Time frame: 24 weeks
- Comparison of viral load curves from all visits between the two groups.
Time frame: 24 weeks
Codivir® safety by comparison of treatment-emergent adverse events in both groups.
Time frame: 24 weeks
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 6 Nov 2024.
- Individual participant dataSharing planned: No
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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 ICF, Eligibility Assessment and Demographic data in people with HIV and HIV Infection, run by Code Pharma 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 8 inclusion and 11 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 6 Nov 2024. 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 Nadya Lisovoder, MD (0524753435, nadyal@galilee-cbr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.