A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT ID: NCT00135395
Last Updated: 2010-02-05
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
200 participants
INTERVENTIONAL
2004-05-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Atazanavir+ritonavir
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
B
Lopinavir+ritonavir
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
Interventions
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Atazanavir+ritonavir
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Lopinavir+ritonavir
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
* Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
* The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA \< 400 c/mL)
Exclusion Criteria
* Reported virologic failure to two or more antiretroviral regimens
* Active AIDS-defined opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
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
Hobson City, Alabama, United States
Local Institution
Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Mateo, California, United States
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Tarzana, California, United States
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West Hollywood, California, United States
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Norwalk, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Safety Harbor, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Berkley, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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East Orange, New Jersey, United States
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Hillsborough, New Jersey, United States
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Jersey City, New Jersey, United States
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Brooklyn, New York, United States
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Mount Vernon, New York, United States
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New York, New York, United States
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Valhalla, New York, United States
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Greenville, North Carolina, United States
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Huntersville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Hampton, Virginia, United States
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Santruce, , Puerto Rico
Countries
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Other Identifiers
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AI424-103
Identifier Type: -
Identifier Source: org_study_id
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