Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
167 participants
INTERVENTIONAL
2008-11-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atazanavir + Raltegravir
Atazanavir 300 mg twice daily + Raltegravir 400 mg twice daily
Atazanavir
Capsules, Oral, 300 mg, twice daily, 96 weeks
Raltegravir
Tablet, Oral, 400 mg, twice daily, 96 weeks
Atazanavir + Ritonavir + Tenofovir /Emtricitabine
Atazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily
Atazanavir
Capsules, Oral, 300 mg, once daily, 96 weeks
Ritonavir
Capsules, Oral, 100 mg, once daily, 96 weeks
Tenofovir/Emtricitabine
Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks
Interventions
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Atazanavir
Capsules, Oral, 300 mg, twice daily, 96 weeks
Raltegravir
Tablet, Oral, 400 mg, twice daily, 96 weeks
Atazanavir
Capsules, Oral, 300 mg, once daily, 96 weeks
Ritonavir
Capsules, Oral, 100 mg, once daily, 96 weeks
Tenofovir/Emtricitabine
Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV ribonucleic acid (RNA) level \>=5000 copies/mL
* Antiretroviral treatment-naive
* Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
* \<350 cells/mm\^3
* Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:
* Screening HIV RNA level \>100,000 copies/mL, or
* CD4 decline \>50-100 cells/mm\^3/year, or
* Age \>=55 years
* Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
* Medically stable
Exclusion Criteria
* Hepatitis B or hepatitis C coinfection
* History of or current cardiac disease
* Electrocardiogram findings:
* PR Interval \>260 msec (severe 1st degree atrioventricular block)
* QRS Interval \>120 msec
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Southwest Center For HIV/AIDS
Phoenix, Arizona, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
The Aaron Diamond AIDS Research Center
New York, New York, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, P.A.
Houston, Texas, United States
Diversified Medical Practices, P.A.
Houston, Texas, United States
Local Institution
Buenos Aires, Bs As, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Mar del Plata, Buenos Aires, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Nantes, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Countries
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References
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Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI424-376
Identifier Type: -
Identifier Source: org_study_id
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