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.

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

3 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoffmann - La Roche Inc

Nutley, New Jersey, 07110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zalcitabine

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed