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| Name | Class |
|---|---|
| Galilee CBR | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Codivir® | Experimental | 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:
At V6 (week 12) treatment with Codivir® will end. |
|
| Antiretrovirals (ARTs) | Active Comparator | In Weeks 0-24, all participants will receive:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICF | Other | Application of Informed Consent Form. |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 : CD4+ count. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadya Lisovoder, MD | Contact | 0524753435 | nadyal@galilee-cbr.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDSS Research Center | Recruiting | São Paulo | 04037-030 | Brazil |
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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:
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| Eligibility Assessment |
| Behavioral |
Assessment of inclusion, exclusion and discontinuation criteria. |
|
| Demographic data | Other | Collection of demographic data. |
|
| Weight, height and BMI | Diagnostic Test | Weight and height measurement and body mass index calculation. |
|
| Vital Signs | Other | HR, BP and FR and T°, in addition to oximetry. |
|
| Medical evaluation | Diagnostic Test | Medical history and physical examination at screening. In other consultations, the medical evaluation is focused on viral load, CD4+ and new complaints. |
|
| Safety exam | Diagnostic Test | 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. |
|
| Pregnancy test | Diagnostic Test | β-HCG in urine in non-sterile women |
|
| Serology | Diagnostic Test | HBV (HBsAg, Anti-HBc) and HCV (anti-HCV-Ab). |
|
| Randomization | Other | Assignment to the Standard Antiretroviral Treatment + Codivir® group or the Standard Antiretroviral Treatment only group |
|
| Apoptosis markers | Diagnostic Test | Caspases and Annexin V. |
|
| Cell activation markers | Diagnostic Test | PBMCs will be isolated by density gradient centrifugation. The cells will then be tested for CD4+, CD8+, CD38 and HLA DR |
|
| Inflammation markers | Diagnostic Test | ultrasensitive CRP, D-dimer. |
|
| Proviral DNA: | Diagnostic Test | Total HIV DNA will be measured to estimate the size of the viral reservoir throughout the preparation. |
|
| HIV-specific antibodies | Diagnostic Test | Anti-HIV-1 specific antibody titers in plasma. |
|
| HIV viral load (RNA) | Diagnostic Test | Performed on plasma. |
|
| Codivir® Training | Behavioral | The participant is trained to self-inject Codivir® |
|
| Dispensing Codivir® | Drug | the participant receives Codivir® |
|
| Codivir® Accounting | Other | The Codivir® used since the last visit is accounted for |
|
| Concomitant medication | Other | Record of concomitant medications used. |
|
| Adverse events | Other | Collection and recording of adverse events. |
|
| Antiretrovirals | Drug | 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.
|
|
| 24 weeks |
| 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: Quantitative 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D003710 | Demography |
| D001827 | Body Height |
| D015992 | Body Mass Index |
| D011258 | Pregnancy Tests |
| D011897 | Random Allocation |
| D044966 | Anti-Retroviral Agents |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000067029 | Physical Appearance, Body |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D006128 | Growth |
| D048788 | Growth and Development |
| D001699 | Biometry |
| D019411 | Clinical Laboratory Techniques |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000998 | Antiviral Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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