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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002265 |
To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG 114) or N3492 (NIAID ACTG 119).
NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY:
Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC. Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator. Their use may be allowed with interruption of study drug for up to 35 days per episode, for a total of 90 days for the study. If the patient's condition requires chronic administration of these medications, the patient will be discontinued from study medication and followed.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zalcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492 |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Recommended:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
discontinuation from NIAID ACTG 114 or NIAID ACTG 119.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Treatment:
Excluded within 30 days of study entry:
Active substance or alcohol abuse.
United States, California | |
Mount Zion Med Ctr | |
San Francisco, California, United States, 94115 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
United States, Florida | |
Dr Robert Swartz | |
Fort Myers, Florida, United States, 33901 | |
Med Service | |
Miami, Florida, United States, 33125 | |
Ctr for Special Immunology | |
Fort Lauderdale, Florida, United States, 33308 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, Pennsylvania | |
Graduate Hosp | |
Philadelphia, Pennsylvania, United States, 19146 | |
United States, Texas | |
Humana Hosp / Med City Dallas | |
Dallas, Texas, United States, 75230 |
Study ID Numbers: | 031C, N3526A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002265 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Zalcitabine Drug Evaluation Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zalcitabine Zidovudine AIDS-Related Complex |
Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |