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A Study to Compare Two Anti-HIV Drug Combinations

NCT ID: NCT00002447

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Brief Summary

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The purpose of this study is to compare 2 anti-HIV drug combinations.

Detailed Description

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Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ritonavir

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Saquinavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
* Are at least 18.
* Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken any anti-HIV medications for more than 2 weeks.
* Are pregnant or breast-feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Principal Investigators

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JSG Montaner

Role: PRINCIPAL_INVESTIGATOR

Ann Collier

Role: STUDY_CHAIR

Danielle Rouleau

Role: STUDY_CHAIR

Michael Saag

Role: STUDY_CHAIR

Paul Volberding

Role: STUDY_CHAIR

Sharon Walmsley

Role: STUDY_CHAIR

Nicholas Bellos

Role: STUDY_CHAIR

Alfred Burnside

Role: STUDY_CHAIR

Stephen Follansbee

Role: STUDY_CHAIR

Joseph Gathe

Role: STUDY_CHAIR

Bruce Hathaway

Role: STUDY_CHAIR

Margaret Hoffman-Terry

Role: STUDY_CHAIR

Jazila Mantis

Role: STUDY_CHAIR

Joseph Masci

Role: STUDY_CHAIR

Mahmoud Mustafa

Role: STUDY_CHAIR

John Schrank

Role: STUDY_CHAIR

Malte Schutz

Role: STUDY_CHAIR

Leon Smith

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, Alabama, United States

Site Status

St Mary's Med Ctr

Long Beach, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Kaiser Foundation Hospital

San Francisco, California, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Physicans Home Service

Washington D.C., District of Columbia, United States

Site Status

Associates in Research

Fort Myers, Florida, United States

Site Status

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, United States

Site Status

Illinois Masonic Med Ctr

Chicago, Illinois, United States

Site Status

Saint Michael's Med Ctr / Dept of Infectious Diseases

Newark, New Jersey, United States

Site Status

Infectious Disease Specialists of NJ

Union, New Jersey, United States

Site Status

Elmhurst Hosp

Elmhurst, New York, United States

Site Status

Queens Hospital Center

Jamaica, New York, United States

Site Status

LIJMC

New Hyde Park, New York, United States

Site Status

East Carolina Univ School of Medicine

Greenville, North Carolina, United States

Site Status

Lehigh Valley Hosp

Allentown, Pennsylvania, United States

Site Status

Burnside Clinic

Columbia, South Carolina, United States

Site Status

Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Nicholas Bellos

Dallas, Texas, United States

Site Status

Joseph Gathe

Houston, Texas, United States

Site Status

Univ of Utah

Salt Lake City, Utah, United States

Site Status

Univ of Washington / AIDS Clinical Trial Unit

Seattle, Washington, United States

Site Status

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Site Status

Toronto Gen Hosp

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de la Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

Ponce Univ Hosp

Ponce, , Puerto Rico

Site Status

Countries

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United States Canada Puerto Rico

Other Identifiers

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NR15720C/M61027

Identifier Type: -

Identifier Source: secondary_id

229R

Identifier Type: -

Identifier Source: org_study_id