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Home > "A" Clinical Trials Conditions > A Comparison of 141W94 and Indinavir in HIV-Infected Patients  A Comparison of 141W94 and Indinavir in HIV-Infected Patients
A Comparison of 141W94 and Indinavir in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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: 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.
Total Enrollment: 460
Location and Contact Information:
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Community Research Initiative of Central Florida
Maitland, Florida, 32751
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
United States
Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Saint Francis Mem Hosp
San Francisco, California, 94109
United States
CRI of South Florida
Coral Gables, Florida, 33146
United States
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
ViRx Inc
San Francisco, California, 94109
United States
Harlem Hosp
New York City, New York, 10027
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Whitman Walker Clinic Inc
Washington D.C., District of Columbia, 20009
United States
Med College of Ohio / Division of Infectious Diseases
Toledo, Ohio, 43614
United States
Methodist Hosp
Memphis, Tennessee, 38104
United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136
United States
Community Oriented Primary Care
Dallas, Texas, 75217
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985400
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: 264E; PROA/B3006
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002202
Other Hiv Infections Studies:
1. Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
2. Consent for Use of Stored Patient Specimens for Future Testing
3. Epicutaneous 1-Chloro-2, 4-dinitrobenzene (DNCB) Patch in HIV Infection.
4. Study of Itraconazole in Patients with Advanced HIV Infection
5. Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Comparison of 141W94 and Indinavir in HIV-Infected Patients
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