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

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002117

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: Zidovudine Drug: Zalcitabine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study
Official Title:	A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Zalcitabine

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

528

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV infection.
CD4 count 100 - 500 cells/mm3.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002117

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Locations

United States, California
Kaiser Permanente Med Ctr
Los Angeles, California, United States, 90027
Kaiser Foundation Hosp
Harbor City, California, United States, 90710
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Sharp Rees - Stealy Med Group
San Diego, California, United States, 92101
United States, Colorado
Denver Public Health Dept / Disease Control Services
Denver, Colorado, United States, 80204
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
Howard Univ
Washington, District of Columbia, United States, 20060
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Georgia
Intergrated Care Ctr
Atlanta, Georgia, United States, 30327
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, Minnesota
St Paul Ramsey Med Ctr / HIV Program Office
St. Paul, Minnesota, United States, 55101
United States, Missouri
Washington Univ
St. Louis, Missouri, United States, 63110
United States, New Mexico
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Bronx Veterans Affairs Med Ctr
Bronx, New York, United States, 10468
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 97201
United States, Texas
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
United States, Wisconsin
Dr Brian Buggy
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Study ID Numbers:	220A, NV 14257
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002117 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Zalcitabine
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009