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Because a higher rate of virological failures in study versus control arm.
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Objectives of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MARAVIROC, DARUNAVIR/r | Experimental | Treatment simplification from a "standard" combined antiretroviral therapy including 3 drugs to Maraviroc plus Darunavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy |
|
| current ART with 3 drugs | Sham Comparator | Patients on HAART with three drugs and HIV RNA below 50 copies/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc, Darunavir/r | Drug | Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure | 96 weeks | |
| Time to virological failure at survival analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea De Luca, Prof | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
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| 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 |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| current antiretroviral therapy with 3 drugs |
| Drug |
To continue the assumption of previous HAART |
|
| 48 weeks |
| Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping) | 48 weeks |
| Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks | 96 weeks |
| Evolution of adherence and quality of life after 24, 48 and 96 weeks | 96 weeks |
| Evolution of maraviroc, darunavir, ritonavir plasma concentrations during the 96 weeks | 96 weeks |
| Evolution of metabolic parameters at 96 weeks | 96 weeks |
| Change of the results of neurocognitive tests at 48 and 96 weeks | 96 weeks |
| Modification of bone density and subcutaneous fat at 48 and 96 weeks | 96 weeks |
| Modification of Intima-Media Thickness and Flow Mediated Dilation at 48 and 96 weeks | 96 weeks |
| Economic impact of Darunavir/ritonavir+ Maraviroc versus Highly Active Antiretroviral Therapy | 96 weeks |
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |