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

February 3, 2010 updated by: Bristol-Myers Squibb

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Santruce, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Hobson City, Alabama, United States
        • Local Institution
      • Montgomery, Alabama, United States
        • Local Institution
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • 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
        • Local Institution
    • Connecticut
      • Norwalk, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Atlantis, Florida, United States
        • Local Institution
      • Fort Lauderdale, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • Miami Beach, 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
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Decatur, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
      • Springfield, Massachusetts, United States
        • Local Institution
    • Michigan
      • Berkley, Michigan, United States
        • Local Institution
    • Mississippi
      • Jackson, Mississippi, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • Nevada
      • Las Vegas, Nevada, United States
        • Local Institution
    • New Jersey
      • East Orange, New Jersey, United States
        • Local Institution
      • Hillsborough, New Jersey, United States
        • Local Institution
      • Jersey City, New Jersey, United States
        • Local Institution
    • New York
      • 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
        • Local Institution
    • North Carolina
      • Greenville, North Carolina, United States
        • Local Institution
      • Huntersville, North Carolina, United States
        • Local Institution
      • Winston Salem, North Carolina, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
      • Galveston, Texas, United States
        • Local Institution
      • Harlingen, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
    • Virginia
      • Hampton, Virginia, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Atazanavir+ritonavir
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Other Names:
  • Reyataz
Active Comparator: B
Drug: Lopinavir+ritonavir
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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