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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002081
• Other study ID #: 031E
• Secondary ID: NV14147C
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients with advanced HIV infection. To observe serious toxicities in this population.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Zidovudine

• Zalcitabine

Locations

Country	Name	City	State
United States	ddC Coordinating Ctr	Wellesley Hills	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)