NCT06676410

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Code Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-11-06
• Last updated: 2024-11-06

Locations

1 site across 1 country: Brazil