Study: NCT06676410

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ICF
Description: Application of Informed Consent Form.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: ICF
Description: Application of Informed Consent Form.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Eligibility Assessment
Description: Assessment of inclusion, exclusion and discontinuation criteria.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Eligibility Assessment
Description: Assessment of inclusion, exclusion and discontinuation criteria.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Demographic data
Description: Collection of demographic data.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Demographic data
Description: Collection of demographic data.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Weight, height and BMI
Description: Weight and height measurement and body mass index calculation.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Weight, height and BMI
Description: Weight and height measurement and body mass index calculation.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Vital Signs
Description: HR, BP and FR and T°, in addition to oximetry.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Vital Signs
Description: HR, BP and FR and T°, in addition to oximetry.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Medical evaluation
Description: Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Medical evaluation
Description: Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Safety exam
Description: Blood collection for safety laboratory exams. Blood count, Na, K, U, C, amylase, total cholesterol and fractions, triglycerides, coagulation tests (TTTP, TT, platelets), TGO, TGP, AP, GGT, glycated hemoglobin, total bilirubin and fractions, creatine kinase and CKmB and urine I.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Safety exam
Description: Blood collection for safety laboratory exams. Blood count, Na, K, U, C, amylase, total cholesterol and fractions, triglycerides, coagulation tests (TTTP, TT, platelets), TGO, TGP, AP, GGT, glycated hemoglobin, total bilirubin and fractions, creatine kinase and CKmB and urine I.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Pregnancy test
Description: β-HCG in urine in non-sterile women

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pregnancy test
Description: β-HCG in urine in non-sterile women

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Serology
Description: HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Serology
Description: HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Randomization
Description: Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Randomization
Description: Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Apoptosis markers
Description: Caspases and Annexin V.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Apoptosis markers
Description: Caspases and Annexin V.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Cell activation markers
Description: PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Cell activation markers
Description: PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Inflammation markers
Description: ultrasensitive CRP, D-dimer.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Inflammation markers
Description: ultrasensitive CRP, D-dimer.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Proviral DNA:
Description: Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Proviral DNA:
Description: Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: HIV-specific antibodies
Description: Anti-HIV-1 specific antibody titers in plasma.