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Clinical Trials

MainTitle

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
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00135395

First received: August 25, 2005
Last updated: February 3, 2010
Last Verified: July 2008
History of Changes
Purpose

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.

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.

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135395

Locations

United States, Alabama
Local Institution
Hobson City, Alabama, United States
Local Institution
Montgomery, Alabama, United States
United States, Arizona
Local Institution
Phoenix, Arizona, United States
United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
Local Institution
Bakersfield, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
San Francisco, California, United States
Local Institution
San Mateo, California, United States
Local Institution
Tarzana, California, United States
Local Institution
West Hollywood, California, United States
United States, Connecticut
Local Institution
Norwalk, Connecticut, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Atlantis, Florida, United States
Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Jacksonville, Florida, United States
Local Institution
Miami Beach, Florida, United States
Local Institution
Miami, Florida, United States
Local Institution
North Miami, Florida, United States
Local Institution
Orlando, Florida, United States
Local Institution
Plantation, Florida, United States
Local Institution
Safety Harbor, Florida, United States
Local Institution
Tampa, Florida, United States
United States, Georgia
Local Institution
Atlanta, Georgia, United States
Local Institution
Decatur, Georgia, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
United States, Michigan
Local Institution
Berkley, Michigan, United States
United States, Mississippi
Local Institution
Jackson, Mississippi, United States
United States, Missouri
Local Institution
St. Louis, Missouri, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
United States, New Jersey
Local Institution
East Orange, New Jersey, United States
Local Institution
Hillsborough, New Jersey, United States
Local Institution
Jersey City, New Jersey, United States
United States, New York
Local Institution
Brooklyn, New York, United States
Local Institution
Mt. Vernon, New York, United States
Local Institution
New York, New York, United States
Local Institution
Valhalla, New York, United States
United States, North Carolina
Local Institution
Greenville, North Carolina, United States
Local Institution
Huntersville, North Carolina, United States
Local Institution
Winston Salem, North Carolina, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, South Carolina
Local Institution
Columbia, South Carolina, United States
United States, Texas
Local Institution
Dallas, Texas, United States
Local Institution
Galveston, Texas, United States
Local Institution
Harlingen, Texas, United States
Local Institution
Houston, Texas, United States
United States, Virginia
Local Institution
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

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00135395   History of Changes  
Other Study ID Numbers: AI424-103  
Study First Received: August 25, 2005  
Last Updated: February 3, 2010  

Keywords provided by Bristol-Myers Squibb:

HIV/AIDS
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Atazanavir Sulfate
Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.