An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
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: Zalcitabine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with
symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT),
or who have completed other ddC protocols, or who are ineligible for ongoing clinical
trials.
Clinical Details
Official title: An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
Study design: Treatment, Open Label, Safety Study
Detailed description:
Patients receive ddC and are evaluated at study entry and every 3 months thereafter, until 3
months after ddC becomes approved for pediatric patients or the sponsor deems it necessary to
terminate the protocol.
Eligibility
Minimum age: 3 Months.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- Symptomatic HIV infection.
- Failure on or intolerance to AZT monotherapy OR completed other ddC protocols OR been
ineligible for other ongoing clinical trials.
- Consent of parent or guardian required.
Note:
- Patients who do not meet the eligibility requirements may discuss their cases with the
medical monitor.
Locations and Contacts
Hoffmann - La Roche Inc, Nutley, New Jersey 07110, United States
Additional Information
Related publications: Adkins JC, Peters DH, Faulds D. Zalcitabine. An update of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in the management of HIV infection. Drugs. 1997 Jun;53(6):1054-80. Review.
Last updated: June 23, 2005
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