A Comparison of 141W94 and Indinavir in HIV-Infected Patients

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002202

Run by

Glaxo Wellcome

People needed

460

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.