Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06676410

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

Led by Code Pharma · Updated on 2024-11-06

40

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

Sponsors

C

Code Pharma

Lead Sponsor

G

Galilee CBR

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female sex
  • Age 18 years or older
  • Confirmed HIV infection by serology and RNA test
  • No prior antiretroviral treatment
  • Viral load greater than 1,000 and less than 50,000 copies/mL
  • CD4 T cell count greater than 350 cells/mm3
  • Body weight over 50 kg at screening
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or planning pregnancy
  • Body mass index under 18.5 kg/m2 at screening
  • Coinfection with hepatitis B or C virus
  • Any Grade 3 or 4 significant abnormality per DAIDS scale
  • Any significant acute illness within 1 week before treatment
  • Use of immunomodulatory therapy, systemic steroids, or chemotherapy within 4 weeks before screening
  • Presence of active or ongoing cancer
  • Abnormal safety lab tests including low neutrophils, hemoglobin, or platelets, or elevated creatinine, bilirubin, AST, or ALT
  • Known allergy or hypersensitivity to Codivir4 components
  • Participation in another clinical trial within the last 12 months
  • Any medical condition making participation unsafe or unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RDSS Research Center

São Paulo, Brazil, 04037-030

Actively Recruiting

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Research Team

N

Nadya Lisovoder, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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