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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA. [Срок оценки: 12 weeks]
• Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count [Срок оценки: 12 weeks]

Вторичные конечные точки (9)

• Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count. [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA) [Срок оценки: 24 weeks]
• Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA) [Срок оценки: 24 weeks]
• - Comparison of viral load curves from all visits between the two groups. [Срок оценки: 24 weeks]
• Codivir® safety by comparison of treatment-emergent adverse events in both groups. [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• RDSS Research Center — São Paulo

Идентификаторы

NCT: NCT06676410 · CP-22-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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