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Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002081
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients with advanced HIV infection. To observe serious toxicities in this population.

Condition Intervention
HIV Infections Drug: Zidovudine Drug: Zalcitabine

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease

Resource links provided by NLM:


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

Detailed Description:
Patients are treated with 1 of 2 doses of ddC administered orally (PO) in combination with AZT administered PO (patients who are unable to tolerate this dose of AZT may receive a lower dose).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Concomitant use of investigational compounds for prophylaxis or treatment of opportunistic infections or other treatments provided use of those compounds with ddC-AZT is considered safe.

Patients must have:

  • Documented HIV infection OR documented AIDS-defining opportunistic infection or neoplasm.
  • Previous AIDS-defining opportunistic infection, neoplasm, or condition OR CD4 lymphocyte count equal to or less than 300 cells/mm3 if symptomatic ORCD4 lymphocyte count equal to or less than 200 cells/mm3 if asymptomatic.
  • Patients must not be currently enrolled in or must be unable to enter an AIDS Clinical Trials Group (ACTG), Community Programs for Clinical Research on AIDS (CPCRA), or other controlled clinical program because of patient ineligibility, distance from trial site, or patient refusal.
  • Patients currently enrolled in any controlled clinical trial of an anti-HIV compound may enter this program only if they have met the end points required for termination of that trial.
  • Patients may be co-enrolled in clinical programs of investigational compounds being tested for prophylaxis or treatment of opportunistic infections or other treatments provided that program allows ddC-AZT combination use, and concomitant administration of the other investigational drug and ddC-AZT is considered safe by the investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Any clinical or laboratory toxicity or abnormality, particularly the presence or history of moderate to severe peripheral neuropathy, that would pose an undue risk to the patient upon initiation of ddC-AZT treatment.
  • Pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002081


Locations
United States, Massachusetts
ddC Coordinating Ctr
Wellesley Hills, Massachusetts, United States, 021810003
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Publications:
Walker M, Moyle GJ, Harris R, Warburg M. Safety and efficacy of zalcitabine (ddC) and zidovudine (ZDV) combination in HIV-positive persons with CD4 cell counts less than or equal to 300/mm3: an international open label evaluation (Roche study M50002). Int Conf AIDS. 1996 Jul 7-12;11(1):77 (abstract no MoB1129)

ClinicalTrials.gov Identifier: NCT00002081     History of Changes
Other Study ID Numbers: 031E
NV14147C
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: June 1992

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Zalcitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents


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