A Study to Compare Two Anti-HIV Drug Combinations

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002447
• Other study ID #: 229R
• Secondary ID: NR15720C/M61027
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: October 1999

Study information

• Verified date: January 2001
• 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 compare 2 anti-HIV drug combinations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ritonavir

• Efavirenz

• Saquinavir

Locations

Country	Name	City	State
Canada	Centre Hospitalier de la Universite de Montreal (CHUM)	Montreal	Quebec
Canada	Toronto Gen Hosp	Toronto	Ontario
Canada	Saint Paul's Hosp	Vancouver	British Columbia
Puerto Rico	Ponce Univ Hosp	Ponce
United States	Lehigh Valley Hosp	Allentown	Pennsylvania
United States	Univ of Alabama at Birmingham / AIDS Outpatient Clinic	Birmingham	Alabama
United States	Illinois Masonic Med Ctr	Chicago	Illinois
United States	Burnside Clinic	Columbia	South Carolina
United States	Nicholas Bellos	Dallas	Texas
United States	Elmhurst Hosp	Elmhurst	New York
United States	Associates in Research	Fort Myers	Florida
United States	East Carolina Univ School of Medicine	Greenville	North Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	Joseph Gathe	Houston	Texas
United States	Queens Hospital Center	Jamaica	New York
United States	St Mary's Med Ctr	Long Beach	California
United States	Univ of Miami / Jackson Memorial Hosp	Miami	Florida
United States	LIJMC	New Hyde Park	New York
United States	Saint Michael's Med Ctr / Dept of Infectious Diseases	Newark	New Jersey
United States	Univ of Utah	Salt Lake City	Utah
United States	Kaiser Foundation Hospital	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Univ of Washington / AIDS Clinical Trial Unit	Seattle	Washington
United States	Infectious Disease Specialists of NJ	Union	New Jersey
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Physicans Home Service	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,