A Comparison of 141W94 and Indinavir in HIV-Infected Patients
NCT ID: NCT00002202
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Amprenavir
Eligibility Criteria
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Inclusion Criteria
* Documented HIV infection.
* HIV RNA \>= 400 copies/ml within 14 days prior to randomized study drug administration.
* No active AIDS-defining opportunistic infection or disease.
* Signed, informed consent from parent or legal guardian of patients less than 18 years of age.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Unlikely to complete the randomized dosing period.
* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.
* Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.
Concurrent Medication:
Excluded:
* Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
* Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).
* Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons.
* Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
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:
* Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma).
* Protease inhibitor therapy.
* Dose of vaccine through an investigational HIV vaccine trial within the 3 months prior to study drug administration.
* Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons within 30 days of study drug administration.
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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East Bay AIDS Ctr
Berkeley, California, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
ViRx Inc
San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Whitman Walker Clinic Inc
Washington D.C., District of Columbia, United States
CRI of South Florida
Coral Gables, Florida, United States
Community Research Initiative of Central Florida
Maitland, Florida, United States
Univ of Miami Dept of Medicine
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
Community Research Initiative on AIDS
New York, New York, United States
Harlem Hosp
New York, New York, United States
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States
Med College of Ohio / Division of Infectious Diseases
Toledo, Ohio, United States
The Research and Education Group
Portland, Oregon, United States
Methodist Hosp
Memphis, Tennessee, United States
Community Oriented Primary Care
Dallas, Texas, United States
Univ of Texas Med Branch
Galveston, Texas, United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Countries
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Other Identifiers
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PROA/B3006
Identifier Type: -
Identifier Source: secondary_id
264E
Identifier Type: -
Identifier Source: org_study_id