Search / Trial NCT00000978

A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine 300 mg per 4 weeks.
  • Drugs unlikely to cause increased toxicity with either study drug and unlikely to cause peripheral neuropathy.
  • Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity, that patient has been taking and tolerating well for ongoing condition.
  • Acyclovir (= or < 600 mg/day, orally).
  • Ketoconazole (= or < 400 mg/day).
  • Nystatin (occasional).
  • Acetaminophen or nonsteroidal antiinflammatory agents (low dose).
  • Drugs that could possibly cause serious additive toxicity when coadministered with either study drug, but unlikely to cause peripheral are allowed only if their use is anticipated for treatment of acute intercurrent illness or opportunistic infections.
  • Allowed only with a study drug interruption of up to 21 days per episode, for a total of 42 days for the study:
  • Acyclovir (> 600 mg/day).
  • Experimental drugs including ganciclovir.
  • Fluconazole.
  • Systemic pentamidine.
  • Pyrimethamine.
  • Triple sulfa.
  • Ansamycin.
  • Prolonged continuous use of high-dose nonsteroidal antiinflammatory agents.
  • Acetaminophen.
  • Amphotericin.
  • Foscarnet.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy if unlikely to cause peripheral neuropathy if their use is anticipated for treatment of acute intercurrent illness or opportunistic infection.
  • Transfusion for anemia.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active opportunistic infections requiring treatment with unallowed drugs.
  • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within month prior to study entry, or with concurrent neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix.
  • History of peripheral neuropathy or any significant signs or symptoms of neurological disease, or abnormality indicative of peripheral neuropathy.
  • Significant cardiac disease defined as history of ventricular arrhythmias requiring medication, prior myocardial infarction, or history of angina or ischemic changes on electrocardiogram.
  • Significant liver disease as defined by transaminase levels or by history of cirrhosis or ascites.
  • Significant renal disease defined by serum creatinine.
  • Concurrent Medication:
  • Excluded:
  • Experimental drugs including fluconazole, and foscarnet.
  • Immunomodulators including interferon, interleukins, or systemic corticosteroids.
  • Ganciclovir.
  • Neurotoxic drugs.
  • Drugs that could potentially cause peripheral neuropathy, including chloramphenicol, cisplatin, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, vincristine, and nitrofurantoin.
  • Excluded within 4 weeks of study entry:
  • Drugs that have caused significant nephrotoxicity or significant hepatotoxicity (as defined by transaminases).
  • Concurrent Treatment:
  • Excluded:
  • Transfusion dependent.
  • Patients are excluded if unwilling or unable to sign informed consent.
  • Prior Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Dideoxycytidine (ddC).
  • Any other nucleoside antiretrovirals.
  • Positive antibody to HIV using any federally licensed ELISA test kit. Diagnosis of AIDS or AIDS-related complex (ARC).
  • Active substance or alcohol abuse.

Attachments

readout_NCT00000978_2023-12-07.pdf

4.5 MB

NCT00000978_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Diego, California, United States

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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