Evaluating Codivir® with standard HIV treatment for newly diagnosed patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Codivir® when added to standard antiretroviral treatment in participants who are newly diagnosed with HIV. The study involves a two-week lead-in period where participants receive daily subcutaneous injections of Codivir®, followed by a 12-week treatment phase where Codivir® is administered every other day alongside standard antiretrovirals. Participants' viral loads will be monitored throughout the study, and those who experience treatment failure will be referred for the best available care. The trial aims to determine if Codivir® can enhance treatment outcomes for HIV-infected individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy, lactation or plan to become pregnant;
2. BMI \< 18.5 kg/m2 at screening;
3. Coinfection with HBV (HBSAg +) or HCV;
4. Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)\* rating scale;
5. Any significant acute illness within 1 week before V0.
6. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening;
7. Active malignancy or ongoing malignancy;
8. 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;
9. Potential allergy or hypersensitivity to components of the Codivir® formulation.
10. Participation in another clinical trial within 12 months of screening.
11. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.

Where it's running

• RDSS Research Center
  São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Nadya Lisovoder, MD
• Email: nadyal@galilee-cbr.com
• Phone: 0524753435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.