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

Code Pharma1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年7月20日最近更新: 2024年11月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 40
试验地点: 1
主要终点: Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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 V
•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.