Clinical trial NCT00002202: A Comparison of 141W94 and Indinavir in HIV-Infected Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
RNA, Viral
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

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