A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

NCT ID: NCT00002117

Last Updated: 2005-06-24

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

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.

Detailed Description

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Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Zalcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count 100 - 500 cells/mm3.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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Kaiser Foundation Hosp

Harbor City, California, United States

Site Status

Kaiser Permanente Med Ctr

Los Angeles, California, United States

Site Status

Sharp Rees - Stealy Med Group

San Diego, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Denver Public Health Dept / Disease Control Services

Denver, Colorado, United States

Site Status

Howard Univ

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

Site Status

Veterans Administration Med Ctr

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

Site Status

Miami Veterans Administration Med Ctr

Miami, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Intergrated Care Ctr

Atlanta, Georgia, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

New England Med Ctr

Boston, Massachusetts, United States

Site Status

St Paul Ramsey Med Ctr / HIV Program Office

Saint Paul, Minnesota, United States

Site Status

Washington Univ

St Louis, Missouri, United States

Site Status

Univ of New Mexico School of Medicine

Albuquerque, New Mexico, United States

Site Status

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, United States

Site Status

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Bronx Veterans Affairs Med Ctr

The Bronx, New York, United States

Site Status

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States

Site Status

Oregon Health Sciences Univ

Portland, Oregon, United States

Site Status

N Texas Ctr for AIDS & Clin Rsch

Dallas, Texas, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Dr Brian Buggy

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NV 14257

Identifier Type: -

Identifier Source: secondary_id

220A

Identifier Type: -

Identifier Source: org_study_id