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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002118
Enrollment
600
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Zalcitabine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Brief 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.

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.

Interventions

DRUGZalcitabine

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 11 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026