Evaluating Codivir® with standard HIV treatment for newly diagnosed patients

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

This study is testing if adding a new drug called Codivir® to standard HIV treatment can help newly diagnosed patients have better health outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Code Pharma (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo)
• Trial ID: NCT06676410 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are newly diagnosed with HIV and meet specific viral load and CD4 count criteria.

Not a fit: Patients who are pregnant, have significant comorbidities, or are currently undergoing other immunomodulatory treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option that improves treatment outcomes for patients with HIV.

How similar studies have performed: While there have been studies exploring new treatments for HIV, the specific combination of Codivir® with standard antiretroviral therapy is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

São Paulo

• RDSS Research Center — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Nadya Lisovoder, MD

Conditions HIV; HIV Infection; AIDS