A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.

Key facts

Study ID

NCT00000823

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

85

Expected to finish

2000-02-01

Last updated by the study team

2021-10-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV-1 seropositivity.
• CD4 count >= 550 cells/mm3.
• Asymptomatic disease.
• No prior antiretroviral therapy.
• Consent of parent or guardian if less than 18 years old.
• PER AMENDMENT 6/18/96:
• Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Medical condition that precludes study compliance.
• Concurrent Medication:
• Excluded:
• Antiretrovirals other than study drugs.
• Biologic response modifiers including erythropoietin and G-CSF.
• Systemic corticosteroids.
• Systemic cytotoxic chemotherapy.
• Intravenous pentamidine.
• Concurrent Treatment:
• Excluded:
• Systemic radiation therapy.
• Patients with the following prior conditions are excluded:
• History of grade 2 or worse peripheral neuropathy.
• History of pancreatitis or factors predisposing to pancreatitis.
• Prior Medication:
• Excluded:
• Prior antiretrovirals.
• Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry.
• Chronic alcoholism.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
• Illinois Masonic Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Brigham and Women's Hosp — Boston, Massachusetts, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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