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.

Conditions

• HIV
• HIV Infection

Interventions

OTHER

ICF

Application of Informed Consent Form.

BEHAVIORAL

Eligibility Assessment

Assessment of inclusion, exclusion and discontinuation criteria.

OTHER

Demographic data

Collection of demographic data.

DIAGNOSTIC_TEST

Weight, height and BMI

Weight and height measurement and body mass index calculation.

OTHER

Vital Signs

HR, BP and FR and T°, in addition to oximetry.

DIAGNOSTIC_TEST

Medical evaluation

Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Pregnancy test

β-HCG in urine in non-sterile women

DIAGNOSTIC_TEST

Serology

HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).

OTHER

Randomization

Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group

DIAGNOSTIC_TEST

Apoptosis markers

Caspases and Annexin V.

DIAGNOSTIC_TEST

Cell activation markers

PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR

DIAGNOSTIC_TEST

Inflammation markers

ultrasensitive CRP, D-dimer.

DIAGNOSTIC_TEST

Proviral DNA:

Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.

DIAGNOSTIC_TEST

HIV-specific antibodies

Anti-HIV-1 specific antibody titers in plasma.

DIAGNOSTIC_TEST

HIV viral load (RNA)

Performed on plasma.

BEHAVIORAL

Codivir® Training

The participant is trained to self-inject Codivir®

DRUG

Dispensing Codivir®

the participant receives Codivir®

OTHER

Codivir® Accounting

The Codivir® used since the last visit is accounted for

OTHER

Concomitant medication

Record of concomitant medications used.

OTHER

Adverse events

Collection and recording of adverse events.

DRUG

Antiretrovirals

Tenofovir - inhibits HIV-1 reverse transcriptase activity by competing with the natural substrate, deoxyadenosine 5'-triphosphate and, upon incorporation into DNA, causes DNA chain termination. * Lamivudine - potent selective inhibitor of HIV-1 and HIV-2 replication in vitro. * Darunavir - prevents the formation of mature infective viral particles, indicated for the treatment of the human immunodeficiency virus (HIV), which causes AIDS. * Ritonavir: antiretroviral protease inhibitor, widely used in combination with other protease inhibitors in the therapy and prevention of HIV infection, which causes the syndrome acquired immunodeficiency (AIDS). * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day

Sponsors & Collaborators

• Galilee CBR

  collaborator INDUSTRY

• Code Pharma

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-20

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Brazil

Study Locations