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A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

NCT ID: NCT00002168

Last Updated: 2007-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.

Detailed Description

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100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Conditions

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HIV Infections

Keywords

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Didanosine Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Clinic

Berkeley, California, United States

Site Status

Harbor UCLA Med Ctr / Division of Immunology / N-24

Torrance, California, United States

Site Status

Anderson Clinical Research

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

Site Status

George Washington Med Ctr / Clinical Trials Unit

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

Site Status

Chicago Ctr for Clinical Research

Chicago, Illinois, United States

Site Status

Northwestern Univ

Chicago, Illinois, United States

Site Status

Univ of Nebraska

Omaha, Nebraska, United States

Site Status

Univ of North Carolina / Infectious Disease Division

Chapel Hill, North Carolina, United States

Site Status

The Nalle Clinic / Clinical Research Dept

Charlotte, North Carolina, United States

Site Status

Univ of Pennsylvania / Infectious Diseases Division

Philadelphia, Pennsylvania, United States

Site Status

Southwest Infectious Disease Association / PA

Dallas, Texas, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Hosp Regional de Ponce - Area Vieja

Ponce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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BMS 002

Identifier Type: -

Identifier Source: secondary_id

260B

Identifier Type: -

Identifier Source: org_study_id