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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 Othe - Article


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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.

Sponsored by: Hoffmann-La Roche
Information provided by: AIDS Clinical Trials Information Service

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

Further Study Details: 

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.

Study ID Numbers:  031F; NV14610
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

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Page Updated: June 1, 2005
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