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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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