Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

February 3, 2010 updated by: Bristol-Myers Squibb

A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.

Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, 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
    • Florida
      • Miami, Florida, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, 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

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:

  • HIV positive
  • LPV/RTV-based HAART for at least 6 months
  • HIV-1 RNA less than 50c/mL (confirmed)
  • Non-HDL higher than 160 mg/dL
  • CD4 of at least 50 cells/mL

Exclusion Criteria:

  • Use of lipid-lowering agents

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: G1
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
Other Names:
  • Reyataz
Active Comparator: G2
Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)
Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.

Secondary Outcome Measures

Outcome Measure
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.

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

January 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

July 12, 2005

First Submitted That Met QC Criteria

July 15, 2005

First Posted (Estimate)

July 18, 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, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-100

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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