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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002118
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002118 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
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Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Zalcitabine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
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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.
Both
3 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002118
031F, NV14610
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Hoffmann-La Roche
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Not Provided
NIH AIDS Clinical Trials Information Service
August 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP