Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
Recruiting · NCT06676410 · Interventional (participants receive a specific treatment) · Lead sponsor: Code Pharma
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- RDSS Research Center - São Paulo, Brazil