Clinical trial NCT00002081: Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease
Official title: Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Zalcitabine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wellesley Hills
country: United States
facility: ddC Coordinating Ctr
state: Massachusetts
Study officials:
References:
citation: 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)