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

Overview

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.

Interventions

• Other ICF
  Application of Informed Consent Form.
• Behavioral Eligibility Assessment
  Assessment of inclusion, exclusion and discontinuation criteria.
• Other Demographic data
  Collection of demographic data.
• Diagnostic test Weight, height and BMI
  Weight and height measurement and body mass index calculation.
• Other Vital Signs
  HR, BP and FR and T°, in addition to oximetry.
• Diagnostic test Medical evaluation
  Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
• Diagnostic test 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.
• Diagnostic test Pregnancy test
  β-HCG in urine in non-sterile women
• Diagnostic test Serology
  HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
• Other Randomization
  Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• RDSS Research Center — São Paulo

Identifiers

NCT: NCT06676410 · CP-22-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗