A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
NCT ID: NCT00135343
Last Updated: 2011-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2004-04-30
2005-10-31
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
NONE
Study Groups
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A
Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
B
Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Interventions
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Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
* Antiretroviral (ARV) naive prior to enrollment
* Normal plasma triglycerides ≤ 200 mg/dL
* Women of child-bearing age must use effective barrier contraception
Exclusion Criteria
* Evidence of resistance to antiretroviral drugs
* History of elevated blood cholesterol or triglycerides
* History of diabetes
* Hypersensitivity to any component of the study drugs
* Any cholesterol or triglyceride lowering medications in the past six months
* Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months
* Imprisonment or involuntary incarceration for medical treatment
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
San Francisco, California, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Atlantis, Florida, United States
Local Institution
Orlando, Florida, United States
Local Institution
South Miami, Florida, United States
Local Institution
Tampa, Florida, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Berkley, Michigan, United States
Local Institution
St Louis, Missouri, United States
Local Institution
Huntersville, North Carolina, United States
Local Institution
Clumbia, South Carolina, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Hampton, Virginia, United States
Countries
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Other Identifiers
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AI424-121
Identifier Type: -
Identifier Source: org_study_id
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