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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002202 |
Purpose
The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Amprenavir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Pharmacokinetics Study |
| Official Title: | A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy (except local treatment for Kaposi's sarcoma).
Patients with the following prior conditions are excluded:
Clinically relevant pancreatitis or hepatitis within the last 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).
Risk Behavior:
Excluded:
Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.
Required:
NRTI therapy at day of entry and up to screening.
Required:
>= 12 weeks of NRTI therapy.
Contacts and Locations
Hide Study Locations| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| ViRx Inc | |
| San Francisco, California, United States, 94109 | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Whitman Walker Clinic Inc | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| Univ of Miami Dept of Medicine | |
| Miami, Florida, United States, 33136 | |
| Community Research Initiative of Central Florida | |
| Maitland, Florida, United States, 32751 | |
| CRI of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Boston Med Ctr / Evans - 556 | |
| Boston, Massachusetts, United States, 021182393 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985400 | |
| United States, New York | |
| Community Research Initiative on AIDS | |
| New York, New York, United States, 10001 | |
| Harlem Hosp | |
| New York, New York, United States, 10027 | |
| United States, North Carolina | |
| The Nalle Clinic / Clinical Research Dept | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Ohio | |
| Med College of Ohio / Division of Infectious Diseases | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oregon | |
| The Research and Education Group | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Methodist Hosp | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Baylor College of Medicine / Dept of Medicine | |
| Houston, Texas, United States, 770303498 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 775550835 | |
| Community Oriented Primary Care | |
| Dallas, Texas, United States, 75217 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
More Information
| Study ID Numbers: | 264E, PROA/B3006 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002202 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Indinavir RNA, Viral |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |