A Study of ddC in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Have Not Had Success With Zidovudine (AZT)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002279
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1991
  Purpose

AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate that ddC monotherapy is safe, and tolerable in this patient population.

Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that ddC monotherapy is safe and tolerable in the treatment of patients who previously experienced either treatment failure, hematologic intolerance or myositis with AZT treatment and pancreatitis or other toxicities (except peripheral neuropathy with ddI).


Condition Intervention
HIV Infections
Drug: Zalcitabine

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Dideoxycytidine (Ro 24-2027). An Open-Label, Safety Study 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:

Detailed Description:

The first 50 patients enrolled into the study will be with investigators having prior ddC experience, specifically AIDS Clinical Trials Group (ACTG), or non-ACTG investigators who are listed in ddC protocols NIAID ACTG 012, 112, 047, 050, 106 (N3447), 114 (N3300), 119 (N3492), N3226, or investigators at any ACTG center or ACTG satellite centers with knowledge of ddC therapy.

Once all 50 patients have been entered and 25 have completed four weeks of treatment the study will be dependent upon receipt of completed case forms up to week #4 of treatment for the 25 patients who have been reviewed and evaluated for safety.

Patients 51-200 may then be entered by any physician licensed in his or her state who has experience with AIDS patients and agrees to follow the patients as specified in the protocol. After all 200 have been entered and week #16 case report forms are returned to the ddC Coordinating Center and reviewed for safety for 100 of the 200 patients, the protocol would be open without limit on numbers of patients.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Recommended:

  • Aerosolized Pentamidine or other prophylaxis against Pneumocystis carinii pneumonia (PCP).
  • Allowed:
  • Drugs or treatments that could cause other serious additive toxicity when coadministered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator.
  • Isoniazid, if there is no evidence of peripheral neuropathy at entry and the patient is taking pyridoxine = or > 50 mg/day.
  • Metronidazole, only with a study drug interruption; neurological exam should be performed before and after treatment with metronidazole and ddC restarted only if there are no signs, symptoms or neurological findings suggestive of peripheral neuropathy.
  • It is recommended that patients requiring amphotericin, pyrimethamine, sulfadiazine, intravenous trimethoprim / sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir or acyclovir = or > 1000 mg/day orally or other bone marrow or renal toxic drugs have an interruption of ddC until they are stable for two weeks on a maintenance dose of the above medications and only then can ddC be restarted.
  • Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim / sulfamethoxazole, ganciclovir, intravenous acyclovir or 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.

Concurrent Treatment:

Allowed:

  • Radiation therapy with dideoxycytidine (ddC) interruption until stable for 2 weeks on treatment.

AMENDED:

  • Treatment categories are now:
  • AZT treatment failure. AZT intolerance. AZT ineligibility

Original design:

  • Patients must have a diagnosis of AIDS or AIDS-related complex (ARC) and fall into one of the following 2 categories:
  • Zidovudine (AZT) treatment failure and dideoxyinosine (ddI) intolerance or AZT intolerance and ddI intolerance. Under 18 years of age must have the consent of a parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms 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 neurological exam. If 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.
  • Neoplasms other than Kaposi's sarcoma or basal cell carcinoma.

Concurrent Medication:

Excluded:

  • Other experimental drugs.
  • Other retroviral nucleoside analogs.
  • Immunomodulators Systemic corticosteroids.
  • Drugs with known nephrotoxic or hepatotoxic potential.
  • Drugs likely to cause peripheral neuropathy.
  • Avoid due to potential to cause peripheral neuropathy:
  • Chloramphenicol.
  • Iodoquinol.
  • Phenytoin.
  • Ethionamide.
  • Gold.
  • Ribavirin.
  • Vincristine.
  • Cisplatin.
  • Dapsone.
  • Disulfiram.
  • Glutethimide.
  • Hydralazine.
  • Nitrofurantoin.

Patients with the following are excluded:

  • Any history of peripheral neuropathy due to any cause.
  • Any finding suggestive of peripheral neuropathy found at baseline neurological exam.
  • Neoplasms other than Kaposi's sarcoma or basal cell carcinoma.
  • 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: NCT00002279

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

Publications:
Abrams D, Goldman A, Launer C, Korvick J, Crane L, Deyton L. Results of a randomized open-label comparison trial of ddI and ddC in HIV infected patients who are intolerant of or have failed ZDV therapy; CPCRA 002. The Terry Beirn Community Programs for Clinical Research on AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):67 (abstract no WS-B24-4)

ClinicalTrials.gov Identifier: NCT00002279     History of Changes
Other Study ID Numbers: 031B, N3544C
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
Didanosine
Drugs, Investigational
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
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
Zalcitabine
Zidovudine
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 August 19, 2014