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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135395
First Posted: August 26, 2005
Last Update Posted: February 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Condition Intervention Phase
HIV Infections Drug: Atazanavir+ritonavir Drug: Lopinavir+ritonavir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12

Secondary Outcome Measures:
  • Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.

Estimated Enrollment: 200
Study Start Date: May 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Atazanavir+ritonavir
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Other Name: Reyataz
Active Comparator: B Drug: Lopinavir+ritonavir
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age infected with HIV
  • 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:

  • Pregnancy or breastfeeding
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135395


  Hide Study Locations
Locations
United States, Alabama
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Hobson City, Alabama, United States
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Montgomery, Alabama, United States
United States, Arizona
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Phoenix, Arizona, United States
United States, Arkansas
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Little Rock, Arkansas, United States
United States, California
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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
United States, Connecticut
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Norwalk, Connecticut, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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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 Beach, Florida, United States
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Miami, 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
United States, Georgia
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Kentucky
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Louisville, Kentucky, United States
United States, Louisiana
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New Orleans, Louisiana, United States
United States, Massachusetts
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
United States, Michigan
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Berkley, Michigan, United States
United States, Mississippi
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Jackson, Mississippi, United States
United States, Missouri
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St. Louis, Missouri, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New Jersey
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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
United States, New York
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Brooklyn, New York, United States
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Mt. Vernon, New York, United States
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New York, New York, United States
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Valhalla, New York, United States
United States, North Carolina
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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
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
United States, South Carolina
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Columbia, South Carolina, United States
United States, Texas
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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
United States, Virginia
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Hampton, Virginia, United States
Puerto Rico
Local Institution
Santruce, Puerto Rico
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00135395     History of Changes
Other Study ID Numbers: AI424-103
First Submitted: August 25, 2005
First Posted: August 26, 2005
Last Update Posted: February 5, 2010
Last Verified: July 2008

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Atazanavir Sulfate
Protease Inhibitors
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors