Clinical trial NCT06676410: Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HIV
HIV Infection
Keywords: HIV
AIDS
Lead sponsor: Code Pharma
Sponsor class: INDUSTRY
Collaborators: name: Galilee CBR
First posted: 2024-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization

Forty participants with a recent diagnosis of HIV infection, without previous antiretroviral treatment and indication to start antiretroviral treatment, will be randomized as follows:

* 20 participants will receive Standard Antiretroviral Treatment + Codivir
* 20 participants will only receive Standard Antiretroviral Treatment A randomization will be balanced by sex and age.
Primary purpose: TREATMENT

Brief summary: 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.


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 \&gt; 1,000 and \&lt; 50,000 copies/mL;
6. CD4 T lymphocyte (CD4) cell count \&gt;350 cells/mm3;
7. Body weight at V -1 \&gt; 50 Kg;
8. Signature of the ICF.

Exclusion Criteria:

1. Pregnancy, lactation or plan to become pregnant;
2. BMI \&lt; 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 \&lt; 1000 u/L; Hb \&lt; 9.0 gm/dl; platelet \&lt; 75,000 u/L; creatinine \&gt; 1.5 mg/dl, direct bilirubin \&gt; 85 μmol/l, AST or ALT \&gt; 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.

Primary outcomes:
measure: Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA.
timeFrame: 12 weeks
measure: Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count
timeFrame: 12 weeks
Secondary outcomes:
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count.
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA)
timeFrame: 24 weeks
measure: Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA)
timeFrame: 24 weeks
measure: - Comparison of viral load curves from all visits between the two groups.
timeFrame: 24 weeks
measure: Codivir® safety by comparison of treatment-emergent adverse events in both groups.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: RDSS Research Center
Study officials:
References: