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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000823 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 85 |
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.
Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks.
PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
PER AMENDMENT 6/18/96:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Chronic alcoholism.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
Illinois Masonic Med Ctr | |
Chicago, Illinois, United States, 606575147 | |
Louis A Weiss Memorial Hosp | |
Chicago, Illinois, United States, 60640 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
Methodist Hosp of Indiana / Life Care Clinic | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hosp | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 981224304 |
Study Chair: | Collier AC | |
Study Chair: | Johnson V |
Study ID Numbers: | ACTG 276 |
Study First Received: | November 2, 1999 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00000823 |
Health Authority: | United States: Federal Government |
Didanosine Drug Therapy, Combination Zidovudine Drug Administration Schedule |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |