Completed

Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen

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What is being tested

Atazanavir

+ Nelfinavir mesylate

+ Stavudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: May 4, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

NCT00002240
Principal SponsorBristol-Myers Squibb
Last updated: May 4, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

Inclusion Criteria 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. Exclusion Criteria 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Clinsites / Sorra Research Ctr

Birmingham, United StatesOpen Clinsites / Sorra Research Ctr in Google Maps

Univ of Alabama at Birmingham

Birmingham, United States

UCSD Treatment Ctr

San Diego, United States

UCSF - San Francisco Gen Hosp

San Francisco, United States
Completed17 Study Centers