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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001107-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.
A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATV/r+3TC | Experimental | Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day. |
|
| ATV/r+2 NRTIs | Active Comparator | Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir boosted Atazanavir + Lamivudine | Drug | ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs | Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs | Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 24 weeks of treatment | week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José A Pérez-Molina, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Elche | Elche | Alicante | Spain | |||
| Hospital Marina Baixa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26062881 | Derived | Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Santos J, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GESIDA 7011 Study Group. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):775-84. doi: 10.1016/S1473-3099(15)00097-3. Epub 2015 Jun 7. |
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|
| Ritonavir boosted Atazanavir + 2 NRTIs | Drug | ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day. |
|
| To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs |
Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 96 weeks of treatment |
| week 96 |
| To assess safety after 24 weeks fo treatment | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. | Week 24 |
| To assess safety after 48 weeks fo treatment | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. | Week 48 |
| To assess safety after 96 weeks fo treatment | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. | Week 96 |
| To assess the incidence of resistance, and characterization of this resistance following a virological rebound | Genotypic antiretroviral resistance profiles of subjects experiencing virologic failure (genotype) Plasma samples at Baseline and at each visit will be stored for additional resistance studies (i.e. cDNA) | Week 96 |
| To assess neurocognitive function evolution | Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48 | Week 48 |
| To assess neurocognitive function evolution | Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96 | Week 96 |
| Villajoyosa |
| Alicante |
| Spain |
| H. Germans Trias i Pujol | Badalona | Barcelona | Spain |
| Hospital General de Granollers | Granollers | Barcelona | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | Spain |
| H. Juan Ramón Jiménez | Huelva | Huelva | Spain |
| Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | La Coruña | Spain |
| H. San Pedro | Logroño | La Rioja | Spain |
| Hospital Príncipe de Asturias | Alcalá de Henares | Madrid | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | Spain |
| H. Clinico San Carlos | Madrid | Madrid | Spain |
| H. Universitario Infanta Leonor | Madrid | Madrid | Spain |
| H. Universitario Son Espases | Mallorca | Mallorca | Spain |
| Hospital Costa del Sol | Marbella | Málaga | Spain |
| Hospital Arquitecto Marcide | Ferrol | Pontevedra | Spain |
| Hospital Xeral Cíes | Vigo | Pontevedra | Spain |
| H. Universitario Central de Asturias | Asturias | Principality of Asturias | Spain |
| Hospital de Basurto | Basurto | Vizcaya | Spain |
| Hospital Juan Canalejo | A Coruña | Spain |
| Hospital General de Alicante | Alicante | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital Reina Sofía | Córdoba | Spain |
| Hospital Clínico San Cecilio | Granada | Spain |
| Hospital Virgen de las Nieves | Granada | Spain |
| Hospital Doce de Octubre | Madrid | Spain |
| Hospital Gregorio Marañón | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital de Mataró | Mataró | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Hospital de Navarra | Pamplona | Spain |
| Hospital Donostia | San Sebastián | Spain |
| Hospital Marqués de Valdecilla | Santander | Spain |
| Hospital de Santa Tecla | Tarragona | Spain |
| Hospital La Fe | Valencia | Spain |
| 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 |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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