A Study to Compare Two Anti-HIV Drug Combinations - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study to Compare Two Anti-HIV Drug Combinations

Official Title ^ICMJE

An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Brief Summary

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

Detailed Description

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Ritonavir
Drug: Efavirenz
Drug: Saquinavir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

146

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00002447

Responsible Party

Study ID Numbers ^ICMJE

229R, NR15720C/M61027

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	JSG Montaner
Study Chair:	Ann Collier
Study Chair:	Danielle Rouleau
Study Chair:	Michael Saag
Study Chair:	Paul Volberding
Study Chair:	Sharon Walmsley
Study Chair:	Nicholas Bellos
Study Chair:	Alfred Burnside
Study Chair:	Stephen Follansbee
Study Chair:	Joseph Gathe
Study Chair:	Bruce Hathaway
Study Chair:	Margaret Hoffman-Terry
Study Chair:	Jazila Mantis
Study Chair:	Jazila Mantis
Study Chair:	Joseph Masci
Study Chair:	Mahmoud Mustafa
Study Chair:	John Schrank
Study Chair:	Malte Schutz
Study Chair:	Leon Smith

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP