Evaluating Codivir with Standard Antiretroviral Therapy for Treatment-Naive Adults with HIV Infection

What this Trial Is About

Researchers are evaluating the use of Codivir4 in addition to standard antiretroviral treatment ART for adults with HIV infection who have not yet received antiretroviral therapy. This phase 2 clinical trial aims to study the efficacy and safety of combining Codivir4 with a common ART regimen in participants with confirmed HIV infection and specific viral load and immune cell counts. Participants must be at least 18 years old and have a controlled body weight. The study begins with a two-week lead-in period where participants assigned to Codivir4 receive a daily 2 mL subcutaneous injection, while those in the standard treatment group wait. Starting at week 0, all participants begin the standard ART regimen, which includes a daily single tablet combining Tenofovir, Lamivudine, Darunavir, and Ritonavir. Additionally, those in the Codivir4 group receive Codivir4 injections every other day for 12 weeks. Codivir4 treatment ends at week 12, and the full study participation concludes at week 24. Participants will undergo regular monitoring, including viral load and CD4 cell count assessments, as well as blood tests for safety and markers of immune activation, apoptosis, and inflammation. Self-injection training and medication accounting are part of the study visits. The primary outcomes focus on changes in viral reservoir size and CD4 counts at week 12. Safety and other immune-related markers are evaluated through week 24. If viral load indicates treatment failure, participants will be withdrawn and referred for appropriate care.

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