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Clinical Trials in Brazil / NCT06676410
Recruiting Phase 2

Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants

NCT06676410 · tracked via the Priya Life Science Brazil tracker
Sponsor
Code Pharma
Phase
Phase 2
Started
2023-07-20
Last updated
2024-11-06

Condition(s) studied

HIVHIV Infection

Investigational drug(s) / intervention(s)

ICFEligibility AssessmentDemographic dataWeight, height and BMIVital SignsMedical evaluationSafety examPregnancy testSerologyRandomizationApoptosis markersCell activation markersInflammation markersProviral DNA:HIV-specific antibodiesHIV viral load (RNA)Codivir® TrainingDispensing Codivir®Codivir® AccountingConcomitant medicationAdverse eventsAntiretrovirals

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

Study 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male or female sex; 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: 1. Pregnancy, lactation or plan to become pregnant; 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
RDSS Research Center São Paulo Brazil Recruiting

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HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676410 on ClinicalTrials.gov ↗ ← All trials in Brazil