Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

April 28, 2011 updated by: Bristol-Myers Squibb

Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
      • Ottawa, Ontario, Canada
        • Ottawa General Hospital
      • Toronto, Ontario, Canada
        • Toronto Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Chest Institute
  • France
      • Bordeaux, France
        • Hopital Pellegrin Tripode
      • Nantes, France
        • Hôpital de l'Hôtel Dieu
      • Nice, France
        • Hôpital de l'Archet 1
      • Paris Cedex 13, France
        • Srev Du Pr Gentilini
      • Pessac, France
        • Hopital De Haut Leveque
      • Tourcoing, France
        • Hospital Gustave Dron
      • Villejuif, France
        • Hôpital Paul Brousse
  • Germany
      • Hamburg, Germany
        • Brennerstr 71
      • Hanover, Germany
        • Georg-Str 46
      • Munich, Germany
        • Praxisgemeinschaft
  • Italy
      • Antella, Italy
        • Reparto Malattie Infettive
      • Milano, Italy
        • Clinical Malattie Infettive
      • Milano, Italy
        • Ospedale Luigi Cacco Moroni
      • Modena, Italy
        • Clinical Malattie Infettive / Univ Modena
      • Rimini, Italy
        • Ospedale Degli Infermi
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Sorra Research Ctr / Med Forum
    • California
      • Los Angeles, California, United States, 90027
        • Aids Healthcare Foundation
      • Oakland, California, United States, 94609
        • Robert Scott MD
      • Sacramento, California, United States, 95817
        • Univ of California - Davis Med Ctr / CARES
      • Tarzana, California, United States, 91356
        • Avalar Medical Group
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Univ School of Medicine / AIDS Program
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative of South Florida
      • Fort Lauderdale, Florida, United States, 33316
        • HIV Clinical Research
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • New York, New York, United States, 10011
        • St Vincents Hosp / Clinical Research Program
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosps of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • El Paso, Texas, United States, 79905
        • Texas Tech Health Sciences Ctr
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network / Div of Montrose Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
  • Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
  • Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
  • Will most likely respond well to the study drugs, as shown by the results of a lab test.
  • Are at least 18 years old.
  • Agree to use effective barrier methods of birth control (such as condoms).
  • Are available for follow-up for at least 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
  • Have only recently become HIV positive.
  • Abuse alcohol or drugs.
  • Have severe diarrhea within 30 days of study entry.
  • Have hemophilia.
  • Have a history of pancreatitis.
  • Have hepatitis within 30 days of study entry.
  • Have peripheral neuropathy (a painful condition affecting the nervous system).
  • Are unable to take medications by mouth.
  • Are pregnant or breast-feeding.

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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)
  • Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 302B
  • AI424-009

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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