A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

NCT ID: NCT00002369

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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To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Detailed Description

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100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + 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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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

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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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

HIV Clinical Research Ctr

Fort Lauderdale, Florida, United States

Site Status

Infectious Disease Research Institute Inc

Tampa, Florida, United States

Site Status

Advance Clinical Research

Atlanta, Georgia, United States

Site Status

Louisiana State Univ Med Ctr / HIV Outpatient Clinic

New Orleans, Louisiana, United States

Site Status

Boston Univ Med Ctr Hosp / Evans - 556

Boston, Massachusetts, United States

Site Status

Community Research Initiative of New England

Brookline, Massachusetts, United States

Site Status

Washington Univ School of Medicine

St Louis, Missouri, United States

Site Status

Blackstock Family Health Ctr

Austin, Texas, United States

Site Status

Hosp Regional de Ponce - Area Vieja

Ponce, , Puerto Rico

Site Status

San Juan AIDS Program

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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BMS 001

Identifier Type: -

Identifier Source: secondary_id

260A

Identifier Type: -

Identifier Source: org_study_id