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This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir Emtricitabine Raltegravir | Experimental | Patients switching to raltegravir with tenofovir+emtricitabine as backbone |
|
| Lamivudine Abacavir Raltegravir | Experimental | Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone |
|
| Abacavir free | Experimental | Patients switched to raltegravir whose backbone therapy should not be randomized in order to avoid the use of abacavir (HLA-B*5701 positive patients,Framingham score 20% or higher) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir emtricitabine raltegravir | Drug | switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone |
|
| Measure | Description | Time Frame |
|---|---|---|
| To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis | 48 weeks | |
| Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis |
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Inclusion Criteria:
Patients treated with a combined antiretroviral therapy from at least 1 year
Aged 18 years or older
With one or more of the following conditions:
With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
Who gave informed consent to the participation to the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico A. Gemelli | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Lamivudine Abacavir Raltegravir | Drug | Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone |
|
| Abacavir free | Drug | Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established. |
|
| 48 weeks |
| Evolution of CD4 cell count during the 48 weeks of study | 48 weeks |
| Evolution of adherence and quality of life during the 48 weeks of study | 48 weeks |
| Evolution of raltegravir plasma concentrations during the 48 weeks of study | 48 weeks |
| Evolution of metabolic parameters during the 48 weeks of study | 48 weeks |
| Change of the results of neurocognitive tests at 48 weeks of study | 48 weeks |
| Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study | 48 weeks |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |