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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002202
• Other study ID #: 264E
• Secondary ID: PROA/B3006
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Amprenavir

Locations

Country	Name	City	State
United States	East Bay AIDS Ctr	Berkeley	California
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Boston Med Ctr / Evans - 556	Boston	Massachusetts
United States	The Nalle Clinic / Clinical Research Dept	Charlotte	North Carolina
United States	Northwestern Univ Med School	Chicago	Illinois
United States	CRI of South Florida	Coral Gables	Florida
United States	Community Oriented Primary Care	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Univ of Texas Med Branch	Galveston	Texas
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Baylor College of Medicine / Dept of Medicine	Houston	Texas
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Community Research Initiative of Central Florida	Maitland	Florida
United States	Methodist Hosp	Memphis	Tennessee
United States	Univ of Miami Dept of Medicine	Miami	Florida
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Community Research Initiative on AIDS	New York	New York
United States	Harlem Hosp	New York	New York
United States	Univ of Nebraska Med Ctr	Omaha	Nebraska
United States	The Research and Education Group	Portland	Oregon
United States	Saint Francis Mem Hosp	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Med College of Ohio / Division of Infectious Diseases	Toledo	Ohio
United States	Whitman Walker Clinic Inc	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,