Actively Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Codivir4 with Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-Na EFve Adults
Led by Code Pharma · Updated on 2024-11-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Code Pharma
Lead Sponsor
G
Galilee CBR
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Codivir4 in addition to standard antiretroviral treatment (ART) for adults with HIV infection who have not yet received antiretroviral therapy. This phase 2 clinical trial aims to study the efficacy and safety of combining Codivir4 with a common ART regimen in participants with confirmed HIV infection and specific viral load and immune cell counts. Participants must be at least 18 years old and have a controlled body weight. The study begins with a two-week lead-in period where participants assigned to Codivir4 receive a daily 2 mL subcutaneous injection, while those in the standard treatment group wait. Starting at week 0, all participants begin the standard ART regimen, which includes a daily single tablet combining Tenofovir, Lamivudine, Darunavir, and Ritonavir. Additionally, those in the Codivir4 group receive Codivir4 injections every other day for 12 weeks. Codivir4 treatment ends at week 12, and the full study participation concludes at week 24. Participants will undergo regular monitoring, including viral load and CD4+ cell count assessments, as well as blood tests for safety and markers of immune activation, apoptosis, and inflammation. Self-injection training and medication accounting are part of the study visits. The primary outcomes focus on changes in viral reservoir size and CD4+ counts at week 12. Safety and other immune-related markers are evaluated through week 24. If viral load indicates treatment failure, participants will be withdrawn and referred for appropriate care.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Male or female sex
- Age 18 years or older
- Confirmed HIV infection by antibody and RNA tests
- No prior antiretroviral treatment
- Viral load between 1,000 and 50,000 copies/mL
- CD4 T lymphocyte count above 350 cells/mm3
- Body weight greater than 50 kg at baseline
- Signed informed consent form
You will not qualify if you...
- Pregnancy, breastfeeding, or planning to become pregnant
- Body mass index less than 18.5 kg/m2 at screening
- Coinfection with hepatitis B or hepatitis C virus
- Any significant clinical abnormality of grade 3 or 4 severity
- Serious acute illness within one week before treatment start
- Use of immunomodulatory therapy, systemic steroids, or chemotherapy within four weeks before screening
- Active or ongoing cancer
- Abnormal safety lab tests including low neutrophils, hemoglobin, platelets, or elevated creatinine, bilirubin, or liver enzymes
- Known allergy or sensitivity to Codivir4 components
- Participation in another clinical trial within the past 12 months
- Any medical condition that increases risk or is unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants randomized to Codivir® receive daily subcutaneous injections of Codivir® for two weeks before starting standard antiretroviral treatment. Participants randomized to standard treatment wait during this time.
Visits at Week -2 and Week -1
Duration - 24 weeks
All participants receive daily antiretroviral therapy for 24 weeks. Participants in the Codivir® group also receive Codivir® injections on alternate days for the first 12 weeks.
Multiple visits from baseline through Week 24, including 1 baseline visit and 6 follow-up visits up to Week 12, plus additional visits to Week 24
Duration - Up to 24 weeks
Participants are monitored for safety and efficacy outcomes after treatment completion.
Visits through Week 24 for ongoing assessments
Trial Site Locations
Total: 1 location
1
RDSS Research Center
São Paulo, Brazil, 04037-030
Actively Recruiting
Research Team
N
Nadya Lisovoder, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here