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A Comparison of 141W94 and Indinavir in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
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.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 460
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002202

  Hide Study Locations
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
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

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

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
RNA, Viral
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009