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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
Sponsored by: 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

MedlinePlus related topics: AIDS
Drug Information available for: Indinavir Indinavir Sulfate VX 478
U.S. FDA Resources
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.

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

  Show 24 Study Locations
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Indinavir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Antitubercular Agents
Retroviridae Infections

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 May 07, 2009