A Comparison of 141W94 and Indinavir in HIV-Infected Patients
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.
2 other identifiers
interventional
460
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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:
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (24)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
ViRx Inc
San Francisco, California, 94109, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Whitman Walker Clinic Inc
Washington D.C., District of Columbia, 20009, United States
CRI of South Florida
Coral Gables, Florida, 33146, United States
Community Research Initiative of Central Florida
Maitland, Florida, 32751, United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985400, United States
Community Research Initiative on AIDS
New York, New York, 10001, United States
Harlem Hosp
New York, New York, 10027, United States
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
Med College of Ohio / Division of Infectious Diseases
Toledo, Ohio, 43614, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Methodist Hosp
Memphis, Tennessee, 38104, United States
Community Oriented Primary Care
Dallas, Texas, 75217, United States
Univ of Texas Med Branch
Galveston, Texas, 775550835, United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11