Zalcitabine |
ddC; dideoxycytidine; Hivid |
Clinical Trial: 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 Othe
This study has been completed.
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Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections | Drug: Zalcitabine |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
Expected Total Enrollment: 600
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
Ages Eligible for Study: 3 Months - 11 Years, Genders Eligible for Study: 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.
Location Information
New Jersey
Hoffmann - La Roche Inc, Nutley, New Jersey, 07110, United States
More Information
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.
Record last reviewed: August 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002118
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Hivid (Drug Digest)
- Zalcitabine (Drug Digest)

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