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

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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Zalcitabine

U.S. FDA Resources

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

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

Show 24 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Study ID Numbers:	220A, NV 14257
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002117
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Zalcitabine

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Communicable Diseases

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008