Last updated 50 days ago

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

40 patients around the world

Available in Brazil

Code Pharma

40Patients around the world

This study is for people with

Hiv

From 18 Years

All Gender

: 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.

: 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.

StudyCodivir®

SponsorCode Pharma

Conditions

Hiv

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06676410