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This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine.
Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simplification | Experimental | Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD) |
|
| Continue with current treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiretroviral treatment | Drug | antiretroviral treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with no treatment failure |
| 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with no viral failure | defined as two viral loads above 50 copies/ml. Patients lost to follow-up or changing treatment will not be taken into account for this analysis | 48 weeks |
| Proportion of patients with no therapeutical failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Ramón Arribas, MD | Hospital Uniuversitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic i Provincial Barcelona | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital Universitario La Paz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26062880 | Derived | Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martinez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabie A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome. |
| 48 weeks |
| Proportion of patients with no viral failure | defined as two viral loads above 400 copies/ml | 48 weeks |
| Time to viral failure | Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold | 48 weeks |
| Proportion of patients with blips | Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml | 48 weeks |
| Change from baseline CD4 | 48 weeks |
| Lipidic profile change from baseline | 48 weeks |
| Creatinine clearance change from baseline | 48 weeks |
| Proportion of patients with proximal tubular renal disfunction | 48 weeks |
| Lipodystrophy changes from baseline | evaluated using two questionnaires: lipoatrophy and fat accumulation | 48 weeks |
| Adherence to treatment | 48 weeks |
| Mortality and progression to AIDS | 48 weeks |
| Adverse events per treatment branch | 48 weeks |
| Proportion of patients switching study treatment due to an adverse event | 48 weeks |
| Proportion of serious adverse events related to treatment | 48 weeks |
| Madrid |
| Madrid |
| 28046 |
| Spain |
| 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 |