Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug); Zalcitabine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients
with advanced HIV infection. To observe serious toxicities in this population.
Clinical Details
Official title: Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease
Study design: Treatment, Open Label, Safety Study
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
ddC Coordinating Ctr, Wellesley Hills, Massachusetts 021810003, United States
Additional Information
Related 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)
Last updated: June 23, 2005
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