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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002202
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
ViRx Inc
San Francisco, California, United States, 94109
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
CRI of South Florida
Coral Gables, Florida, United States, 33146
Community Research Initiative of Central Florida
Maitland, Florida, United States, 32751
Univ of Miami Dept of Medicine
Miami, Florida, United States, 33136
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
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Boston Med Ctr / Evans - 556
Boston, Massachusetts, United States, 021182393
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
Community Oriented Primary Care
Dallas, Texas, United States, 75217
Univ of Texas Med Branch
Galveston, Texas, United States, 775550835
Baylor College of Medicine / Dept of Medicine
Houston, Texas, United States, 770303498
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002202     History of Changes
Other Study ID Numbers: 264E, PROA/B3006
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Indinavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014