Trials
Search / Trial NCT00001022

A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

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

Trial Information

Current as of January 15, 2025

Completed

Keywords

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

ClinConnect Summary

Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Required:
  • Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
  • CD4+ cell count = or \< 200/mm3 or = or \< 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
  • Current PCP prophylaxis.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
  • Stage 2 or worse (moderate) AIDS Dementia Complex.
  • Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.
  • Concurrent Medication:
  • Excluded:
  • Acute therapy for active AIDS-defining opportunistic infection.
  • Systemic chemotherapy for malignancy.
  • Antiretroviral therapy other than that provided by this study.
  • Patients with the following prior conditions are excluded:
  • History of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • History of intolerance to the study drugs at entry doses and/or frequencies.
  • History of phenylketonuria.

Trial Officials

L Saravolatz

Study Chair

D Winslow

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Denver, Colorado, United States

New Haven, Connecticut, United States

Wilmington, Delaware, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Brooklyn, New York, United States

New York, New York, United States

New York, New York, United States

Richmond, Virginia, United States

San Francisco, California, United States

Portland, Oregon, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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