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Home > "A" Clinical Trials Conditions > A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients



A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 825

Location and Contact Information:

Univ of Kentucky / Kentucky Clinic Annex #
Lexington,  Kentucky,  40536
United States
 

AIDS Community Research Consortium
Redwood City,  California,  94063
United States
 

Montefiore Med Ctr
Bronx,  New York,  10467
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Univ of Texas Southwestern Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

Arizona Clinical Research Ctr Inc
Tucson,  Arizona,  85712
United States
 

Mayo Clinic
Rochester,  Minnesota,  55905
United States
 

Dartmouth-Hitchcock Med Ctr
Lebanon,  New Hampshire,  03756
United States
 

UCSF - San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 

Ospedale S Raffaele
Milano,  , 
Italy
 

New York Hosp - Cornell Med Ctr
New York City,  New York,  10021
United States
 

Houston Clinical Research Network
Houston,  Texas,  77004
United States
 

Stratogen Health of Palm Beach
Palm Beach Gardens,  Florida,  33410
United States
 

St Joseph's Hosp & Med Center
Paterson,  New Jersey,  07503
United States
 

Urgent Care Ctr
Ft. Lauderdale,  Florida,  33316
United States
 

Carle Clinic Association
Urbana,  Illinois,  61801
United States
 

Antibiotic Research Associates
Kansas City,  Missouri,  64132
United States
 

Aurora Med Group
Milwaukee,  Wisconsin,  53212
United States
 

Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

Denver Public Health Dept / Disease Control Services
Denver,  Colorado,  80204
United States
 

AIDS Clinical Trials Unit
New York City,  New York,  10016
United States
 

Univ of Massachusetts Med Ctr
Worcester,  Massachusetts,  01655
United States
 

CIGNA
Phoenix,  Arizona,  85006
United States
 

Houston Med Ctr
Houston,  Texas,  77030
United States
 

Saint Joseph's / Mercy Hosp
Ypsilanti,  Michigan,  48197
United States
 

Beer Med Group
Los Angeles,  California,  90036
United States
 

SIU School of Medicine
Springfield,  Illinois,  62702
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263
United States
 

Duval County Health Dept
Jacksonville,  Florida,  32206
United States
 

VAMC New Jersey Healthcare System
East Orange,  New Jersey,  07018
United States
 

Ctr for Quality Care
Tampa,  Florida,  33609
United States
 

Royal Liverpool Univ Hosp
Liverpool,  , 
United Kingdom
 

HIV Wellness Ctr / Univ Med Ctr
Las Vegas,  Nevada,  89102
United States
 

Treasure Coast Infectious Disease Consultants
Vero Beach,  Florida,  32960
United States
 

Carolinas Research Associates
Charlotte,  North Carolina,  28203
United States
 

Infectious Disease Physicians Inc
Annandale,  Virginia,  22203
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

ASC Inc
Aniston,  Alabama,  36201
United States
 

Dr Wilbert Jordan
Paramount,  California,  90723
United States
 

Marin County Specialty Clinic
San Rafael,  California,  94903
United States
 

Roger Williams Med Ctr
Providence,  Rhode Island,  02908
United States
 

Dr Charles Farthing
Los Angeles,  California,  90048
United States
 

ONCOL Med Associates / PA
Houston,  Texas,  77027
United States
 

Allegheny Univ Hosp
Philadelphia,  Pennsylvania,  19129
United States
 

Dr Michael Mullen
New York City,  New York,  10003
United States
 

Community Research Initiative
Brookline,  Massachusetts,  02445
United States
 

Univ of Missouri at Kansas City School of Medicine
Kansas City,  Missouri,  64108
United States
 

St Lukes / Roosevelt Hosp / HIV Center
New York City,  New York,  10019
United States
 

UMDNJ - New Jersey Med School / Cooper Hosp
Camden,  New Jersey,  08103
United States
 

Infectious Disease Research Institute Inc
Tampa,  Florida,  33614
United States
 

Nalle Clinic
Charlotte,  North Carolina,  28207
United States
 

East Carolina Univ School of Medicine
Greenville,  North Carolina,  27858
United States
 

QUEST Clinical Research
San Francisco,  California,  94115
United States
 

Harper Hosp
Detroit,  Michigan,  48201
United States
 

Peter Krueger Clinic
New York City,  New York,  10003
United States
 

Dr Douglas Dieterich
New York City,  New York,  10016
United States
 

Kaiser Permanente, Infectious Disease
Denver,  Colorado,  80205
United States
 

Dr Robert Schwartz
Ft. Myers,  Florida,  33901
United States
 

New York Hosp / Cornell Med Ctr
New York City,  New York,  10021
United States
 

Nassau County Med Ctr
East Meadow,  New York,  11554
United States
 

Anderson Clinical Research
Washington D.C.,  District of Columbia,  20037
United States
 

Medizinische Einrichtungen der Heinrich U
Duesseldorf,  , 
Germany
 

Austin Infectious Disease Consultants
Austin,  Texas,  78705
United States
 

Lehigh Valley Hosp
Allentown,  Pennsylvania,  18105
United States
 

Houston Clinical Research Network
Houston,  Texas,  77098
United States
 

Community Research Initiative
Brookline,  Massachusetts,  02445
United States
 

Dr Ron Grossman
New York City,  New York,  10016
United States
 

Swedish Med Ctr / Dr Peter Shalit
Seattle,  Washington,  98104
United States
 

Brookdale Univ Med Ctr
Brooklyn,  New York,  11212
United States
 

Providence Hosp
Washington D.C.,  District of Columbia,  20037
United States
 

Northwestern Univ Med Ctr
Chicago,  Illinois,  60611
United States
 

Shared Med Research Foundation
Tarzana,  California,  91356
United States
 

Dr Daniel Pearce
San Francisco,  California,  92101
United States
 

Burnside Clinic
Columbia,  South Carolina,  29206
United States
 

New Jersey Community Research Initiative
Newark,  New Jersey,  07103
United States
 

Hosp Valle D Hebron
Barcelona,  , 
Spain
 

San Juan Veterans Administration Med Ctr
San Juan,  ,  009275800
Puerto Rico
 

Alta Bates Med Ctr
Berkeley,  California,  94705
United States
 

Univ of Arizona
Tucson,  Arizona,  85724
United States
 

Stratogen of Ft Lauderdale
Ft. Lauderdale,  Florida,  33334
United States
 

Univ of South Florida
Tampa,  Florida,  33612
United States
 

Oklahoma Univ Health Science Ctr
Oklahoma City,  Oklahoma,  73104
United States
 

AIDS Healthcare Foundation Labs
Los Angeles,  California,  90027
United States
 

Ctr for Special Immunology
Irving,  California,  92718
United States
 

Howard Grossman
New York City,  New York,  10011
United States
 

Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati,  Ohio,  45267
United States
 

Mt Vernon Hosp
Mt. Vernon,  New York,  10550
United States
 

North Texas Infectious Disease Consultants
Dallas,  Texas,  75246
United States
 

IDC Research Initiative
Altamonte Springs,  Florida,  32701
United States
 

Albany Med College / Division of HIV Medicine A158
Albany,  New York,  122083479
United States
 

Infectious Disease Specialists of Atlanta
Decatur,  Georgia,  30033
United States
 

Dr Nicholaos Bellos
Dallas,  Texas,  75225
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Gottlieb Med Group
North Hollywood,  California,  91607
United States
 

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Dr Jay Kostman
Philadelphia,  Pennsylvania,  19140
United States
 

Bowman Gray School of Medicine
Winston Salem,  North Carolina,  27157
United States
 

North Shore Univ Hosp
Manhasset,  New York,  11030
United States
 

Elmhurst Hosp
Elmhurst,  New York,  11373
United States
 

Liberty Med Group
New York City,  New York,  10016
United States
 

Abbott Northwestern Hosp
Minneapolis,  Minnesota,  55407
United States
 

New York / Cornell Med Ctr
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:
  229H;  NR15520,M6101
Study Start Date: 
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002378

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A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

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