Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
Summary
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.
Timeline
- Start
- 2023-07-20
- Primary completion
- 2024-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CODIVIR | Unknown | 2 ml | Subcutaneous |
| Comparator | Darunavir | Small molecule | 800 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | — |
| Comparator | Tenofovir | Small molecule | 300 mg | — |