NCT06676410RecruitingPhase 2
Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Oct 2024
- Start date
- 20 Jul 2023
- Primary completion date
- Dec 2024
- Lead sponsor
- Code Pharma
- Diseases
- HIV
- NCT number
- NCT06676410
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 20 Jul 2023 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Coinfection with HBV (HBSAg +) or HCV;
- Active malignancy or ongoing malignancy;
- Potential allergy or hypersensitivity to components of the Codivir® formulation.
- Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.
Lab values
- 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;
Other
- Pregnancy, lactation or plan to become pregnant;
- BMI \< 18.5 kg/m2 at screening;
- Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)\* rating scale;
- Participation in another clinical trial within 12 months of screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RDSS Research Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.