Overview

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

Status:
RECRUITING

Trial end date:
2024-12-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE2

Details

Lead Sponsor:

Code Pharma

Collaborator:

Galilee CBR

Treatments:

Anti-Retroviral Agents
Body Height
Body Mass Index
Demography
Pregnancy Tests
Random Allocation