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A Study to Compare Two Anti-HIV Drug Combinations | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT00002447

A Study to Compare Two Anti-HIV Drug Combinations

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

Lead sponsor: Hoffmann-La Roche•22 U.S. locations•View source on ClinicalTrials.gov

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What this study is about

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Sponsors

Lead Sponsor

Hoffmann-La Roche

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 24, 2005Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment146

Start dateOct 1999

Last updatedJun 24, 2005

Condition

Locations shown

Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, Alabama

St Mary's Med Ctr

Long Beach, California

UCSF - San Francisco Gen Hosp

San Francisco, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions