Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
NCT ID: NCT06676410
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-07-20
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Codivir®
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.
ICF
Application of Informed Consent Form.
Eligibility Assessment
Assessment of inclusion, exclusion and discontinuation criteria.
Demographic data
Collection of demographic data.
Weight, height and BMI
Weight and height measurement and body mass index calculation.
Vital Signs
HR, BP and FR and T°, in addition to oximetry.
Medical evaluation
Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
Safety exam
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 test
β-HCG in urine in non-sterile women
Serology
HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
Randomization
Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group
Apoptosis markers
Caspases and Annexin V.
Cell activation markers
PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR
Inflammation markers
ultrasensitive CRP, D-dimer.
Proviral DNA:
Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.
HIV-specific antibodies
Anti-HIV-1 specific antibody titers in plasma.
HIV viral load (RNA)
Performed on plasma.
Codivir® Training
The participant is trained to self-inject Codivir®
Dispensing Codivir®
the participant receives Codivir®
Codivir® Accounting
The Codivir® used since the last visit is accounted for
Concomitant medication
Record of concomitant medications used.
Adverse events
Collection and recording of adverse events.
Antiretrovirals (ARTs)
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
ICF
Application of Informed Consent Form.
Eligibility Assessment
Assessment of inclusion, exclusion and discontinuation criteria.
Demographic data
Collection of demographic data.
Weight, height and BMI
Weight and height measurement and body mass index calculation.
Vital Signs
HR, BP and FR and T°, in addition to oximetry.
Medical evaluation
Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
Safety exam
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 test
β-HCG in urine in non-sterile women
Serology
HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
Randomization
Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group
Apoptosis markers
Caspases and Annexin V.
Cell activation markers
PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR
Inflammation markers
ultrasensitive CRP, D-dimer.
Proviral DNA:
Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.
HIV-specific antibodies
Anti-HIV-1 specific antibody titers in plasma.
HIV viral load (RNA)
Performed on plasma.
Concomitant medication
Record of concomitant medications used.
Adverse events
Collection and recording of adverse events.
Antiretrovirals
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
Interventions
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ICF
Application of Informed Consent Form.
Eligibility Assessment
Assessment of inclusion, exclusion and discontinuation criteria.
Demographic data
Collection of demographic data.
Weight, height and BMI
Weight and height measurement and body mass index calculation.
Vital Signs
HR, BP and FR and T°, in addition to oximetry.
Medical evaluation
Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
Safety exam
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 test
β-HCG in urine in non-sterile women
Serology
HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
Randomization
Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group
Apoptosis markers
Caspases and Annexin V.
Cell activation markers
PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR
Inflammation markers
ultrasensitive CRP, D-dimer.
Proviral DNA:
Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.
HIV-specific antibodies
Anti-HIV-1 specific antibody titers in plasma.
HIV viral load (RNA)
Performed on plasma.
Codivir® Training
The participant is trained to self-inject Codivir®
Dispensing Codivir®
the participant receives Codivir®
Codivir® Accounting
The Codivir® used since the last visit is accounted for
Concomitant medication
Record of concomitant medications used.
Adverse events
Collection and recording of adverse events.
Antiretrovirals
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
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years;
3. HIV infection confirmed by serology (Ab for HIV1/HIV2) and HIV1/HIV2 RNA test;
4. Naive for antiretroviral treatment;
5. Viral load \> 1,000 and \< 50,000 copies/mL;
6. CD4 T lymphocyte (CD4) cell count \>350 cells/mm3;
7. Body weight at V -1 \> 50 Kg;
8. Signature of the ICF.
Exclusion Criteria
2. BMI \< 18.5 kg/m2 at screening;
3. Coinfection with HBV (HBSAg +) or HCV;
4. Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)\* rating scale;
5. Any significant acute illness within 1 week before V0.
6. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening;
7. Active malignancy or ongoing malignancy;
8. 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;
9. Potential allergy or hypersensitivity to components of the Codivir® formulation.
10. Participation in another clinical trial within 12 months of screening.
11. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.
18 Years
ALL
No
Sponsors
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Galilee CBR
INDUSTRY
Code Pharma
INDUSTRY
Responsible Party
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Locations
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RDSS Research Center
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-22-03
Identifier Type: -
Identifier Source: org_study_id
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