Clinical trial NCT00002447: A Study to Compare Two Anti-HIV Drug Combinations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Saquinavir
HIV Protease Inhibitors
Ritonavir
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 146
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 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham / AIDS Outpatient Clinic
state: Alabama
city: Long Beach
country: United States
facility: St Mary's Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Physicans Home Service
state: District of Columbia
city: Fort Myers
country: United States
facility: Associates in Research
state: Florida
city: Miami
country: United States
facility: Univ of Miami / Jackson Memorial Hosp
state: Florida
city: Chicago
country: United States
facility: Illinois Masonic Med Ctr
state: Illinois
city: Newark
country: United States
facility: Saint Michael's Med Ctr / Dept of Infectious Diseases
state: New Jersey
city: Union
country: United States
facility: Infectious Disease Specialists of NJ
state: New Jersey
city: Elmhurst
country: United States
facility: Elmhurst Hosp
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: New Hyde Park
country: United States
facility: LIJMC
state: New York
city: Greenville
country: United States
facility: East Carolina Univ School of Medicine
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hosp
state: Pennsylvania
city: Columbia
country: United States
facility: Burnside Clinic
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Nicholas Bellos
state: Texas
city: Houston
country: United States
facility: Joseph Gathe
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah
state: Utah
city: Seattle
country: United States
facility: Univ of Washington / AIDS Clinical Trial Unit
state: Washington
city: Vancouver
country: Canada
facility: Saint Paul's Hosp
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Gen Hosp
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de la Universite de Montreal (CHUM)
state: Quebec
city: Ponce
country: Puerto Rico
facility: Ponce Univ Hosp
Study officials:
name: JSG Montaner
role: PRINCIPAL_INVESTIGATOR
name: Ann Collier
role: STUDY_CHAIR
name: Danielle Rouleau
role: STUDY_CHAIR
name: Michael Saag
role: STUDY_CHAIR
name: Paul Volberding
role: STUDY_CHAIR
name: Sharon Walmsley
role: STUDY_CHAIR
name: Nicholas Bellos
role: STUDY_CHAIR
name: Alfred Burnside
role: STUDY_CHAIR
name: Stephen Follansbee
role: STUDY_CHAIR
name: Joseph Gathe
role: STUDY_CHAIR
name: Bruce Hathaway
role: STUDY_CHAIR
name: Margaret Hoffman-Terry
role: STUDY_CHAIR
name: Jazila Mantis
role: STUDY_CHAIR
name: Joseph Masci
role: STUDY_CHAIR
name: Mahmoud Mustafa
role: STUDY_CHAIR
name: John Schrank
role: STUDY_CHAIR
name: Malte Schutz
role: STUDY_CHAIR
name: Leon Smith
role: STUDY_CHAIR
References: