Clinical trial NCT00002378: A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Official title: A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
Lamivudine
RNA, Viral
Dosage Forms
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 825
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens.

AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (\< 400 copies/ml) at week 24 and week 48.

Detailed description: Patients will be randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) sgc plus 2 new reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus new RTI, and Group C - SQV sgc plus nelfinavir plus new RTI, or SQV sgc plus ritonavir plus 2 new RTIs.

NOTE: "New RTI" is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed.

AS PER AMENDMENT 12/12/97: In this open-label, multicenter, Phase IIIB, comparative study, 825 patients are randomized to treatment arms. (NOTE: 50% of the patients will be treatment naive and 50% will be NRTI experienced.) Further, patients are randomized with stratification based on HIV-1 RNA level (5,000-30,000 copies/ml vs. greater than 30,000 copies/ml) and prior antiretroviral therapy to one of the three study arms.

The drug regimens for the three treatment arms are as follows:

ARM A: Fortovase (FTV), plus 2 new NRTIs\*. ARM B: FTV plus 2 new NRTIs\*. ARM C: FTV plus nelfinavir plus new NRTI\*\*.

* Naive patients in Arm A and Arm B will take: d4T (or zidovudine) plus 3TC unless contraindicated.

  \*\* Naive patients in Arm C will take: d4T, unless contraindicated.
* NRTI experienced patients in Arms A \& B should be treated with 2 NRTIs to which he/she has not been previously exposed. If the patient has only 1 NRTI to which he/she has never been exposed, then the second NRTI can be one that the patient has been previously exposed to from the most distant past.

Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 infection.
* HIV RNA \>= 5000 copies/ml by Amplicor assay.
* Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Prior Medication:

Required:

(Note:

* 50% of the patients will be treatment naive).
* \> 3 months cumulative therapy with antiretrovirals other than non-nucleoside reverse transcriptase inhibitors and/or protease inhibitors.
* Stable antiretroviral therapy for at least 4 weeks prior to enrollment.

Allowed:

* \<= 2 weeks cumulative treatment with protease inhibitors.

AS PER AMENDMENT 12/12/97:

Required:

NRTI experienced patients:

* \> 3 months cumulative therapy with antiretrovirals.
* \<= 2 weeks cumulative previous treatment with non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).
* \<= 2 weeks cumulative previous treatment with protease inhibitors.
* Must have at least one NRTI (preferably two) to which he/she has not been previously exposed.
* Stable antiretroviral therapy defined as within (+/-) 1 log HIV-1 RNA between the 2 most recent values greater than 8 weeks apart (may include screening visit) prior to study enrollment. (NOTE:
* If patient does not have a previous HIV-1 RNA value, screening will be accepted.)

Required:

* Note:
* 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER AMENDMENT 12/12/97.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aniston
country: United States
facility: ASC Inc
state: Alabama
city: Phoenix
country: United States
facility: CIGNA
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Ctr Inc
state: Arizona
city: Tucson
country: United States
facility: Univ of Arizona
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Med Ctr
state: California
city: Irving
country: United States
facility: Ctr for Special Immunology
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation Labs
state: California
city: Los Angeles
country: United States
facility: Beer Med Group
state: California
city: Los Angeles
country: United States
facility: Dr Charles Farthing
state: California
city: North Hollywood
country: United States
facility: Gottlieb Med Group
state: California
city: Paramount
country: United States
facility: Dr Wilbert Jordan
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Francisco
country: United States
facility: Dr Daniel Pearce
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Francisco
country: United States
facility: QUEST Clinical Research
state: California
city: San Rafael
country: United States
facility: Marin County Specialty Clinic
state: California
city: Tarzana
country: United States
facility: Shared Med Research Foundation
state: California
city: Denver
country: United States
facility: Denver Public Health Dept / Disease Control Services
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente, Infectious Disease
state: Colorado
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Anderson Clinical Research
state: District of Columbia
city: Washington
country: United States
facility: Providence Hosp
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: Urgent Care Ctr
state: Florida
city: Fort Lauderdale
country: United States
facility: Stratogen of Ft Lauderdale
state: Florida
city: Fort Myers
country: United States
facility: Dr Robert Schwartz
state: Florida
city: Jacksonville
country: United States
facility: Duval County Health Dept
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Stratogen Health of Palm Beach
state: Florida
city: Tampa
country: United States
facility: Ctr for Quality Care
state: Florida
city: Tampa
country: United States
facility: Univ of South Florida
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med Ctr
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Lexington
country: United States
facility: Univ of Kentucky / Kentucky Clinic Annex #
state: Kentucky
city: Brookline
country: United States
facility: Community Research Initiative
state: Massachusetts
city: Worcester
country: United States
facility: Univ of Massachusetts Med Ctr
state: Massachusetts
city: Detroit
country: United States
facility: Harper Hosp
state: Michigan
city: Ypsilanti
country: United States
facility: Saint Joseph's / Mercy Hosp
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hosp
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Univ of Missouri at Kansas City School of Medicine
state: Missouri
city: Kansas City
country: United States
facility: Antibiotic Research Associates
state: Missouri
city: Las Vegas
country: United States
facility: HIV Wellness Ctr / Univ Med Ctr
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Med Ctr
state: New Hampshire
city: Camden
country: United States
facility: UMDNJ - New Jersey Med School / Cooper Hosp
state: New Jersey
city: East Orange
country: United States
facility: VAMC New Jersey Healthcare System
state: New Jersey
city: Newark
country: United States
facility: New Jersey Community Research Initiative
state: New Jersey
city: Paterson
country: United States
facility: St Joseph's Hosp & Med Center
state: New Jersey
city: Albany
country: United States
facility: Albany Med College / Division of HIV Medicine A158
state: New York
city: Bronx
country: United States
facility: Montefiore Med Ctr
state: New York
city: Brooklyn
country: United States
facility: Brookdale Univ Med Ctr
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Meadow
country: United States
facility: Nassau County Med Ctr
state: New York
city: Elmhurst
country: United States
facility: Elmhurst Hosp
state: New York
city: Manhasset
country: United States
facility: North Shore Univ Hosp
state: New York
city: Mt. Vernon
country: United States
facility: Mt Vernon Hosp
state: New York
city: New York
country: United States
facility: Dr Michael Mullen
state: New York
city: New York
country: United States
facility: Peter Krueger Clinic
state: New York
city: New York
country: United States
facility: Howard Grossman
state: New York
city: New York
country: United States
facility: AIDS Clinical Trials Unit
state: New York
city: New York
country: United States
facility: Dr Douglas Dieterich
state: New York
city: New York
country: United States
facility: Dr Ron Grossman
state: New York
city: New York
country: United States
facility: Liberty Med Group
state: New York
city: New York
country: United States
facility: St Lukes / Roosevelt Hosp / HIV Center
state: New York
city: New York
country: United States
facility: New York / Cornell Med Ctr
state: New York
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
city: New York
country: United States
facility: New York Hosp / Cornell Med Ctr
state: New York
city: New York
country: United States
facility: Harlem Hosp Ctr
state: New York
city: Charlotte
country: United States
facility: Carolinas Research Associates
state: North Carolina
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Univ School of Medicine
state: North Carolina
city: Winston Salem
country: United States
facility: Bowman Gray School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati Med Ctr / Holmes Division
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Univ Health Science Ctr
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hosp
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allegheny Univ Hosp
state: Pennsylvania
city: Philadelphia
country: United States
facility: Dr Jay Kostman
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Columbia
country: United States
facility: Burnside Clinic
state: South Carolina
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Dallas
country: United States
facility: Dr Nicholaos Bellos
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Disease Consultants
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Houston
country: United States
facility: ONCOL Med Associates / PA
state: Texas
city: Houston
country: United States
facility: Houston Med Ctr
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Seattle
country: United States
facility: Swedish Med Ctr / Dr Peter Shalit
state: Washington
city: Milwaukee
country: United States
facility: Aurora Med Group
state: Wisconsin
city: Duesseldorf
country: Germany
facility: Medizinische Einrichtungen der Heinrich U
city: Milano
country: Italy
facility: Ospedale S Raffaele
city: San Juan
country: Puerto Rico
facility: San Juan Veterans Administration Med Ctr
city: Barcelona
country: Spain
facility: Hosp Valle D Hebron
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Univ Hosp
Study officials:
References: