Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy (SALT)
This study is currently recruiting participants.
Verified December 2012 by Fundacion SEIMC-GESIDA
Sponsor:
Fundacion SEIMC-GESIDA
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01307488
First received: March 1, 2011
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Ritonavir boosted Atazanavir + Lamivudine Drug: Ritonavir boosted Atazanavir + 2 NRTIs |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial |
Resource links provided by NLM:
Further study details as provided by Fundacion SEIMC-GESIDA:
Primary Outcome Measures:
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: Week 48 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 24 ] [ Designated as safety issue: No ]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
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 96 ] [ Designated as safety issue: No ]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
- To assess safety after 24 weeks fo treatment [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
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.
- To assess safety after 48 weeks fo treatment [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
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.
- To assess safety after 96 weeks fo treatment [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
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.
- To assess the incidence of resistance, and characterization of this resistance following a virological rebound [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]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)
- To assess neurocognitive function evolution [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
- To assess neurocognitive function evolution [ Time Frame: Week 96 ] [ Designated as safety issue: No ]Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
| Estimated Enrollment: | 325 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ATV/r+3TC
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.
|
Drug: Ritonavir boosted Atazanavir + Lamivudine
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.
|
|
Active Comparator: ATV/r+2 NRTIs
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.
|
Drug: Ritonavir boosted Atazanavir + 2 NRTIs
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signature of informed consent
- At least 18 years old
- Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
- Undetectable viral load for at least 6 months prior to inclusion in the study (VL<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
- Requirement of ARV treatment change due to toxicity, intolerance or simplification.
- Clinically stable.
Exclusion Criteria:
- Pregnant women or women who plan to get pregnant during the study.
- Breast feeding
- History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
- History of ARV treatment change due to virological failure
- History of confirmed virological failure defined as one single VL >400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
- Absence of HIV genotype prior to ARV treatment initiation.
- Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
- HBV infection.
- History of toxicity or intolerance to ATV, RTV or 3TC.
- Gilbert's syndrome.
- Use of contraindicated drugs.
- Lab abnormalities grade 4.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307488
Contacts
| Contact: Miriam Ramirez, BSc | +34 91 556 80 25 | mramirez@f-sg.org |
| Contact: Herminia Esteban, BSc | +34 91 556 80 25 | hesteban@f-sg.org |
Locations
| Spain | |
| Hospital de Elche | Recruiting |
| Elche, Alicante, Spain | |
| Principal Investigator: Félix Gutiérrez, MD | |
| Hospital Marina Baixa | Recruiting |
| Villajoyosa, Alicante, Spain | |
| Principal Investigator: Javier Ena, MD | |
| H. Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain | |
| Principal Investigator: Bonaventura Clotet, MD | |
| Hospital General de Granollers | Recruiting |
| Granollers, Barcelona, Spain | |
| Principal Investigator: Elisabeth Deig, MD | |
| Hospital de Jerez | Recruiting |
| Jerez de la Frontera, Cádiz, Spain | |
| Principal Investigator: Alberto Terrón, MD | |
| Complexo Hospitalario Universitario de Santiago | Recruiting |
| Santiago de Compostela, La Coruña, Spain | |
| Principal Investigator: Antonio Antela, MD | |
| H. San Pedro | Recruiting |
| Logroño, La Rioja, Spain | |
| Principal Investigator: José Antonio Oteo, MD | |
| Hospital Príncipe de Asturias | Recruiting |
| Alcalá de Henares, Madrid, Spain | |
| Principal Investigator: José Sanz, MD | |
| Hospital Severo Ochoa | Recruiting |
| Leganés, Madrid, Spain | |
| Principal Investigator: Miguel Cervero, MD | |
| Hospital Costa del Sol | Recruiting |
| Marbella, Málaga, Spain | |
| Principal Investigator: Julián Olalla, MD | |
| Hospital Arquitecto Marcide | Recruiting |
| El Ferrol, Pontevedra, Spain | |
| Principal Investigator: Ana Mariño, MD | |
| Hospital Xeral Cíes | Recruiting |
| Vigo, Pontevedra, Spain | |
| Principal Investigator: Celia Miralles, MD | |
| Hospital de Basurto | Recruiting |
| Basurto, Vizcaya, Spain | |
| Principal Investigator: Josefa Muñoz, MD | |
| Hospital General de Alicante | Recruiting |
| Alicante, Spain | |
| Principal Investigator: Joaquín Portilla, MD | |
| H. Universitario Central de Asturias | Recruiting |
| Asturias, Spain | |
| Principal Investigator: Victor Asensi, MD | |
| Hospital Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Pere Domingo, MD | |
| Hospital Vall d'Hebrón | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Manel Crespo, MD | |
| Hospital Reina Sofía | Recruiting |
| Córdoba, Spain | |
| Principal Investigator: Antonio Rivero, MD | |
| Hospital Virgen de las Nieves | Recruiting |
| Granada, Spain | |
| Principal Investigator: Juan Pasquau, MD | |
| Hospital Clínico San Cecilio | Recruiting |
| Granada, Spain | |
| Principal Investigator: José Hernández Quero, MD | |
| H. Juan Ramón Jiménez | Recruiting |
| Huelva, Spain | |
| Principal Investigator: Ignacio Martin Suarez, Md | |
| Hospital Juan Canalejo | Recruiting |
| La Coruña, Spain | |
| Principal Investigator: Angeles Castro, MD | |
| Hospital Doce de Octubre | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Rafael Rubio, MD | |
| H. Universitario Infanta Leonor | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Jesús Troya, MD | |
| H. Clinico San Carlos | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Mª Jesus Tellez, MD | |
| Hospital La Paz | Recruiting |
| Madrid, Spain | |
| Principal Investigator: José R Arribas, MD | |
| Hospital Ramón y Cajal | Recruiting |
| Madrid, Spain | |
| Principal Investigator: José A Pérez-Molina, MD | |
| Hospital Gregorio Marañón | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Jaime Cosín, MD | |
| H. Universitario Son Espases | Recruiting |
| Mallorca, Spain | |
| Principal Investigator: Melchor Riera, MD | |
| Hospital de Mataró | Recruiting |
| Mataró, Spain | |
| Principal Investigator: Pilar Barrufet, MD | |
| Hospital Virgen de la Victoria | Recruiting |
| Málaga, Spain | |
| Principal Investigator: Jesús Santos, MD | |
| Hospital de Navarra | Recruiting |
| Pamplona, Spain | |
| Principal Investigator: María Rivero, MD | |
| Hospital Donostia | Recruiting |
| San Sebastián, Spain | |
| Principal Investigator: José A Iribarren, MD | |
| Hospital Marqués de Valdecilla | Recruiting |
| Santander, Spain | |
| Principal Investigator: Santiago Echevarría, MD | |
| Hospital de Santa Tecla | Recruiting |
| Tarragona, Spain | |
| Principal Investigator: Enric Pedrol, MD | |
| Hospital La Fe | Recruiting |
| Valencia, Spain | |
| Principal Investigator: José López-Aldeguer, MD | |
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Bristol-Myers Squibb
Investigators
| Principal Investigator: | José A Pérez-Molina, MD | Hospital Ramón y Cajal |
More Information
No publications provided
| Responsible Party: | Fundacion SEIMC-GESIDA |
| ClinicalTrials.gov Identifier: | NCT01307488 History of Changes |
| Other Study ID Numbers: | GESIDA 7011, 2011-001107-12 |
| Study First Received: | March 1, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Fundacion SEIMC-GESIDA:
|
HIV AIDS Atazanavir Simplification |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Ritonavir |
Atazanavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013