Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002256
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1994
  Purpose

To provide zalcitabine ( ddC ) for patients with AIDS or Advanced ARC in whom zidovudine ( AZT ) is contraindicated, or who have failed treatment with or are intolerant to AZT and to demonstrate that ddC monotherapy is safe, and tolerable in this patient population.


Condition Intervention
HIV Infections
Drug: Zalcitabine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Aerosolized Pentamidine or Trimethoprim/sulfamethoxazole prophylaxis against Pneumocystis carinii pneumonia is recommended.
  • Dapsone is permitted but discouraged.
  • Drugs that could cause other serious toxicity when coadministered with study medication is allowed for treatment of an acute intercurrent illness or opportunistic infection at the investigator's discretion.
  • Any medication that has the potential to cause peripheral neuropathy should be avoided; patients should consult their physicians for specific drugs.
  • Isoniazid is permitted if there is no evidence of peripheral neuropathy at entry and the patient is taking pyridoxine = or > 50 mg/day.
  • Metronidazole is permitted only with a study drug interruption.
  • Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir = or > 1000 mg/day orally 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 (weekly) 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.
  • The following experimental medications are allowed if, in the judgement of the investigator, no serious additive toxicities are anticipated and the experimental drug is necessary for optimal patient management:
  • Ampligen, azithromycin, BW 566C80, bovine colostrum, clarithromycin, diclazuril, foscarnet, oral ganciclovir, GM-CSF, G-CSF, hypericin, IL-2, interferon-beta, interferon-gamma, itraconazole, liposomal amphotericin, liposomal gentamicin, nimodipine, PEG-IL2 (polyethylene glycosylated IL-2), roxithromycin, spiramycin, trimetrexate.

Patients must have the following:

  • AIDS or Advanced ARC.
  • Patients eligible to enter this protocol must fall into one of the following three categories:
  • AZT treatment failure or AZT intolerance or AZT ineligibility or Rollover Patients Under 18 years of age must have the consent of a parent or guardian.

Exclusion Criteria

Patients with the following are excluded:

  • Any history of peripheral neuropathy due to any cause, even if peripheral neuropathy was not the reason for discontinuation of other anti-HIV therapy.
  • Any finding suggestive of peripheral neuropathy found at baseline neurological exam. If a patient has an isolated finding of an absent achilles reflex he may be entered if no signs or symptoms and no other findings are suggestive of peripheral neuropathy.
  • Concomitant treatment with excluded medications. Excluded medications include any other experimental drugs (including ddI), drugs with known nephrotoxic or hepatotoxic potential, and drugs likely to cause peripheral neuropathy. Any = or > Grade 3 laboratory or clinical abnormality or any severe abnormality not listed requires permission from the medical monitor to be entered into this study..
  • Unwillingness or deemed unable to sign informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002256

Locations
United States, New Jersey
Hoffmann - La Roche Inc
Nutley, New Jersey, United States, 071101199
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002256     History of Changes
Other Study ID Numbers: 031D, N3663
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Zalcitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 19, 2014