HIV, HIV Infection
Conditions
Keywords
HIV, AIDS
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.
Interventions
OTHERICF
Application of Informed Consent Form.
BEHAVIORALEligibility Assessment
Assessment of inclusion, exclusion and discontinuation criteria.
OTHERDemographic data
Collection of demographic data.
DIAGNOSTIC_TESTWeight, height and BMI
Weight and height measurement and body mass index calculation.
OTHERVital Signs
HR, BP and FR and T°, in addition to oximetry.
DIAGNOSTIC_TESTMedical evaluation
Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints.
DIAGNOSTIC_TESTSafety exam
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.
DIAGNOSTIC_TESTPregnancy test
β-HCG in urine in non-sterile women
DIAGNOSTIC_TESTSerology
HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab).
OTHERRandomization
Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group
DIAGNOSTIC_TESTApoptosis markers
Caspases and Annexin V.
DIAGNOSTIC_TESTCell activation markers
PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR
DIAGNOSTIC_TESTInflammation markers
ultrasensitive CRP, D-dimer.
DIAGNOSTIC_TESTProviral DNA:
Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation.
DIAGNOSTIC_TESTHIV-specific antibodies
Anti-HIV-1 specific antibody titers in plasma.
DIAGNOSTIC_TESTHIV viral load (RNA)
Performed on plasma.
BEHAVIORALCodivir® Training
The participant is trained to self-inject Codivir®
DRUGDispensing Codivir®
the participant receives Codivir®
OTHERCodivir® Accounting
The Codivir® used since the last visit is accounted for
Record of concomitant medications used.
OTHERAdverse events
Collection and recording of adverse events.
DRUGAntiretrovirals
Tenofovir - inhibits HIV-1 reverse transcriptase activity by competing with the natural substrate, deoxyadenosine 5'-triphosphate and, upon incorporation into DNA, causes DNA chain termination. * Lamivudine - potent selective inhibitor of HIV-1 and HIV-2 replication in vitro. * Darunavir - prevents the formation of mature infective viral particles, indicated for the treatment of the human immunodeficiency virus (HIV), which causes AIDS. * Ritonavir: antiretroviral protease inhibitor, widely used in combination with other protease inhibitors in the therapy and prevention of HIV infection, which causes the syndrome acquired immunodeficiency (AIDS). * 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
Sponsors
Galilee CBR
Code Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: • Estimated viral reservoir size by total blood proviral DNA. | 12 weeks |
| Variation between V-2 (baseline) and V6 (W12) in relation to the following parameter: CD4+ blood count | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter: apoptosis markers | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Cell activation markers | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Inflammation markers | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter : Estimated viral reservoir size by total proviral DNA | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter: HIV viral load (RNA) | 24 weeks |
| - Comparison of viral load curves from all visits between the two groups. | 24 weeks |
| Codivir® safety by comparison of treatment-emergent adverse events in both groups. | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter: Quantitative Proviral (DNA) | 24 weeks |
| Variation between baseline visit and visit 7 (W24) in relation to the following parameter : CD4+ count. | 24 weeks |
Countries
Brazil
Contacts
Primary ContactNadya Lisovoder, MD
Outcome results
None listed