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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001040 |
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC.
SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Saquinavir Drug: Zidovudine Drug: Zalcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication: Required:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Ohio State Univ Hosp | |
Columbus, Ohio, United States, 432101228 | |
United States, Pennsylvania | |
Girard Med Ctr | |
Philadelphia, Pennsylvania, United States, 191046073 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 775550882 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98122 |
Study Chair: | Collier AC | |
Study Chair: | Corey L |
Study ID Numbers: | ACTG 229, NV14255D, FDA 123A |
Study First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00001040 |
Health Authority: | Unspecified |
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Zidovudine Saquinavir HIV Protease Inhibitors |
Virus Diseases Sexually Transmitted Diseases, Viral Saquinavir HIV Infections Zalcitabine Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |