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NCT Number: NCT06676410

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female sex;
  • Age ≥ 18 years;
  • HIV infection confirmed by serology (Ab for HIV1/HIV2) and HIV1/HIV2 RNA test;
  • Naive for antiretroviral treatment;
  • Viral load > 1,000 and < 50,000 copies/mL;
  • CD4 T lymphocyte (CD4) cell count >350 cells/mm3;
  • Body weight at V -1 > 50 Kg;
  • Signature of the ICF.

Exclusion criteria

  • Pregnancy, lactation or plan to become pregnant;
  • BMI < 18.5 kg/m2 at screening;
  • Coinfection with HBV (HBSAg +) or HCV;
  • Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)* rating scale;
  • Any significant acute illness within 1 week before V0.
  • Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening;
  • Active malignancy or ongoing malignancy;
  • Changes in safety tests: neutrophil count < 1000 u/L; Hb < 9.0 gm/dl; platelet < 75,000 u/L; creatinine > 1.5 mg/dl, direct bilirubin > 85 μmol/l, AST or ALT > 2.5 X ULN;
  • Potential allergy or hypersensitivity to components of the Codivir® formulation.
  • Participation in another clinical trial within 12 months of screening.
  • Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.

Treatment and study plan

ICF

Other

Application of Informed Consent Form.

Eligibility Assessment

Behavioral

Assessment of inclusion, exclusion and discontinuation criteria.

Demographic Data

Other

Collection of demographic data.

Weight, height and BMI

Diagnostic Test

Weight and height measurement and body mass index calculation.

Vital signs

Other

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

Medical evaluation

Diagnostic Test

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

Safety exam

Diagnostic Test

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.

pregnancy test

Diagnostic Test

β-HCG in urine in non-sterile women

serology

Diagnostic Test

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

Randomization

Other

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

Apoptosis markers

Diagnostic Test

Caspases and Annexin V.

Cell activation markers

Diagnostic Test

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

Inflammation markers

Diagnostic Test

ultrasensitive CRP, D-dimer.

Proviral DNA:

Diagnostic Test

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

HIV-specific antibodies

Diagnostic Test

Anti-HIV-1 specific antibody titers in plasma.

HIV viral load (RNA)

Diagnostic Test

Performed on plasma.

Codivir® Training

Behavioral

The participant is trained to self-inject Codivir®

Dispensing Codivir®

Drug

the participant receives Codivir®

Codivir® Accounting

Other

The Codivir® used since the last visit is accounted for

Concomitant medication

Other

Record of concomitant medications used.

Adverse events

Other

Collection and recording of adverse events.

Antiretrovirals

Drug

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

Primary outcomes

  1. Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA.

    Time frame: 12 weeks

  2. Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count

    Time frame: 12 weeks

Secondary outcomes

  1. Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA

    Time frame: 24 weeks

  2. Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count.

    Time frame: 24 weeks

  3. Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers

    Time frame: 24 weeks

  4. Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers

    Time frame: 24 weeks

  5. Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers

    Time frame: 24 weeks

  6. Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA)

    Time frame: 24 weeks

  7. Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA)

    Time frame: 24 weeks

  8. - Comparison of viral load curves from all visits between the two groups.

    Time frame: 24 weeks

  9. Codivir® safety by comparison of treatment-emergent adverse events in both groups.

    Time frame: 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Nadya Lisovoder, MD

CONTACT

[email protected]

0524753435

Sponsors and collaborators

Lead sponsor

Code Pharma

Industry

Collaborators

  • Galilee CBR

Registry information

Acronym: Codivir®

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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