NCT00002240

Brief Summary

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 1999

Geographic Reach
2 countries

17 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

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

May 4, 2011

Status Verified

April 1, 2011

Enrollment Period

2.8 years

First QC Date

November 2, 1999

Last Update Submit

April 28, 2011

Conditions

HIV Infections

Keywords

DidanosineDose-Response Relationship, DrugDrug Therapy, CombinationStavudineHIV Protease InhibitorsReverse Transcriptase InhibitorsAnti-HIV AgentsNelfinavir

Interventions

AtazanavirDRUG
Nelfinavir mesylateDRUG
StavudineDRUG
DidanosineDRUG

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 an HIV blood level between 2,000 and 200,000 copies/ml.
  • Have a CD4 cell count of at least 100 cells/mm3.
  • Are 18 years of age or older.
  • Are available for follow-up for at least 48 weeks.
  • Agree to use a barrier method of birth control (such as condoms) during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have ever received anti-HIV (antiretroviral) treatment.
  • Have an HIV-related opportunistic infection or condition at the time of study entry.
  • Have primary HIV infection, meaning they have recently been infected.
  • Have had severe diarrhea within the 30 days before study entry.
  • Have hemophilia.
  • Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
  • Are unable to tolerate oral medication.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Clinsites / Sorra Research Ctr

Birmingham, Alabama, 35203, United States

Location

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UCSD Treatment Ctr

San Diego, California, 92103, United States

Location

UCSF - San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Univ of Colorado / Health Science Ctr

Denver, Colorado, 80262, United States

Location

ViRx / Dupont Circle Physicians Group

Washington D.C., District of Columbia, 20009, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Washington Univ School of Medicine

St Louis, Missouri, 63108, United States

Location

Albany Med College

Albany, New York, 12208, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Oak Lawn Physicians Group

Dallas, Texas, 75219, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Univ TX Galveston Med Branch

Galveston, Texas, 77555, United States

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Related Publications (7)

  • Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12

    BACKGROUND

  • Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)

    BACKGROUND

  • Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26

    BACKGROUND

  • Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)

    BACKGROUND

  • Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)

    BACKGROUND

  • Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)

    BACKGROUND

  • Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir SulfateNelfinavirStavudineDidanosine

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 ProteinsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesRibonucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

March 1, 1999

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

May 4, 2011

Record last verified: 2011-04

Locations

US(16)CA(1)