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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001040 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | ACTG 229, NV14255D, FDA 123A |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001040 History of Changes |
| Health Authority: | Unspecified |
|
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Zidovudine Saquinavir HIV Protease Inhibitors |
|
Antimetabolites Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Saquinavir Acquired Immunodeficiency Syndrome Zalcitabine Zidovudine AIDS-Related Complex |
Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |