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

Code Pharma

Status and phase: Enrolling; Phase 2

Conditions: HIV Infection; HIV

Treatments: Diagnostic Test: HIV-specific antibodies; Behavioral: Eligibility Assessment; Other: ICF; Drug: Antiretrovirals; Diagnostic Test: Pregnancy test; Diagnostic Test: Safety exam; Diagnostic Test: Serology; Diagnostic Test: Inflammation markers; Diagnostic Test: Medical evaluation; Diagnostic Test: Apoptosis markers; Other: Concomitant medication; Other: Codivir® Accounting; Behavioral: Codivir® Training; Other: Demographic data; Other: Vital Signs; Diagnostic Test: HIV viral load (RNA); Diagnostic Test: Proviral DNA:; Diagnostic Test: Weight, height and BMI; Other: Adverse events; Other: Randomization; Drug: Dispensing Codivir®; Diagnostic Test: Cell activation markers

Study type: Interventional

Funder types: Industry

Identifiers

NCT06676410

CP-22-03

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Codivir®

Experimental group

Description:

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. In Weeks 0-24, all participants will receive: * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day 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 (week 12) treatment with Codivir® will end.

Treatment:

Other: Adverse events

Drug: Dispensing Codivir®

Diagnostic Test: Cell activation markers

Other: Randomization

Diagnostic Test: Weight, height and BMI

Diagnostic Test: Proviral DNA:

Diagnostic Test: HIV viral load (RNA)

Other: Vital Signs

Behavioral: Codivir® Training

Other: Demographic data

Other: Concomitant medication

Other: Codivir® Accounting

Diagnostic Test: Apoptosis markers

Diagnostic Test: Medical evaluation

Diagnostic Test: Inflammation markers

Diagnostic Test: Serology

Diagnostic Test: Safety exam

Diagnostic Test: Pregnancy test

Other: ICF

Diagnostic Test: HIV-specific antibodies

Behavioral: Eligibility Assessment

Antiretrovirals (ARTs)

Active Comparator group

Description:

In Weeks 0-24, all participants will receive: * Single solid formulation (in 1 tablet) 1x/day with: * Tenofovir (TDF) 300 mg * Lamivudine (3TC) 300 mg * Darunavir (DRV) 800 mg, 1x/day * Ritonavir (RTV) 100 mg, 1x/day

Treatment:

Other: Adverse events

Diagnostic Test: Cell activation markers

Other: Randomization

Diagnostic Test: Weight, height and BMI

Diagnostic Test: Proviral DNA:

Diagnostic Test: HIV viral load (RNA)

Other: Vital Signs

Other: Demographic data

Other: Concomitant medication

Diagnostic Test: Apoptosis markers

Diagnostic Test: Medical evaluation

Diagnostic Test: Inflammation markers

Diagnostic Test: Serology

Diagnostic Test: Safety exam

Diagnostic Test: Pregnancy test

Drug: Antiretrovirals

Other: ICF

Diagnostic Test: HIV-specific antibodies

Behavioral: Eligibility Assessment