Tests Codivir added to standard treatment in people newly starting HIV medicines
Tests Codivir with standard antiretroviral medicines in adults with HIV not treated before.
Plain-language title generated from the registry record
Registry title: Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Where in Brazil
- RDSS Research CenterSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Code Pharma
- Trial code
- NCT06676410
- Record updated
- 6 November 2024
- Original description
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.Read full original descriptionShow less
Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
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.
Inclusion: 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: 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; Coinfection with HBV (HBSAg +) or HCV; Active malignancy or ongoing malignancy; Potential allergy or hypersensitivity to components of the Codivir® formulation; Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator; 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; Pregnancy, lactation or plan to become pregnant; BMI \< 18.5 kg/m2 at screening; Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)* rating scale; Participation in another clinical trial within 12 months of screening.