NCT00004584

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1999

Geographic Reach
5 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2000

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

May 4, 2011

Status Verified

April 1, 2011

Enrollment Period

2.1 years

First QC Date

February 10, 2000

Last Update Submit

April 28, 2011

Conditions

HIV Infections

Keywords

Dose-Response Relationship, DrugDrug Therapy, CombinationHIV Protease InhibitorsRitonavirSaquinavirReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

AtazanavirDRUG
RitonavirDRUG
SaquinavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Sorra Research Ctr / Med Forum

Birmingham, Alabama, 35203, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 90027, United States

Location

Robert Scott MD

Oakland, California, 94609, United States

Location

Univ of California - Davis Med Ctr / CARES

Sacramento, California, 95817, United States

Location

Avalar Medical Group

Tarzana, California, 91356, United States

Location

Yale Univ School of Medicine / AIDS Program

New Haven, Connecticut, 06510, United States

Location

Community Research Initiative of South Florida

Coral Gables, Florida, 33146, United States

Location

HIV Clinical Research

Fort Lauderdale, Florida, 33316, United States

Location

Infectious Disease Research Institute

Tampa, Florida, 33614, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Louisiana State Univ Med Ctr / HIV Outpatient Clinic

New Orleans, Louisiana, 70112, United States

Location

Albany Med College

Albany, New York, 12208, United States

Location

St Vincents Hosp / Clinical Research Program

New York, New York, 10011, United States

Location

Univ Hosps of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Research and Education Group

Portland, Oregon, 97210, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Vanderbilt Univ Med Ctr

Nashville, Tennessee, 37212, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Texas Tech Health Sciences Ctr

El Paso, Texas, 79905, United States

Location

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, 77006, United States

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Toronto Hosp

Toronto, Ontario, Canada

Location

Montreal Chest Institute

Montreal, Quebec, Canada

Location

Hopital Pellegrin Tripode

Bordeaux, France

Location

Hopital De L'Hotel Dieu

Nantes, France

Location

Hopital De L'Archet 1

Nice, France

Location

Srev Du Pr Gentilini

Paris, France

Location

Hopital De Haut Leveque

Pessac, France

Location

Hospital Gustave Dron

Tourcoing, France

Location

Hopital Paul Brousse

Villejuif, France

Location

Brennerstr 71

Hamburg, Germany

Location

Georg-Str 46

Hanover, Germany

Location

Praxisgemeinschaft

Munich, Germany

Location

Reparto Malattie Infettive

Antella, Italy

Location

Clinical Malattie Infettive

Milan, Italy

Location

Ospedale Luigi Cacco Moroni

Milan, Italy

Location

Clinical Malattie Infettive / Univ Modena

Modena, Italy

Location

Ospedale degli Infermi

Rimini, Italy

Location

Related Publications (2)

  • 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)

    BACKGROUND

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir SulfateRitonavirSaquinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsAzolesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolines

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2000

First Posted

August 31, 2001

Study Start

December 1, 1999

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

May 4, 2011

Record last verified: 2011-04

Locations

FR(7)CA(3)IT(5)US(20)DE(3)