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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ritonavir
Nelfinavir mesylate
Saquinavir
Delavirdine mesylate
Lamivudine
Stavudine
Zidovudine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ASC Inc
  • CIGNA
  • Arizona Clinical Research Ctr Inc
  • Univ of Arizona
  • Alta Bates Med Ctr
  • Ctr for Special Immunology
  • AIDS Healthcare Foundation Labs
  • Beer Med Group
  • Dr Charles Farthing
  • Gottlieb Med Group
  • Dr Wilbert Jordan
  • AIDS Community Research Consortium
  • Dr Daniel Pearce
  • UCSF - San Francisco Gen Hosp
  • Kaiser Permanente Med Ctr
  • QUEST Clinical Research
  • Marin County Specialty Clinic
  • Shared Med Research Foundation
  • Denver Public Health Dept / Disease Control Services
  • Kaiser Permanente, Infectious Disease
  • Georgetown Univ Med Ctr
  • Anderson Clinical Research
  • Providence Hosp
  • IDC Research Initiative
  • Urgent Care Ctr
  • Stratogen of Ft Lauderdale
  • Dr Robert Schwartz
  • Duval County Health Dept
  • Steinhart Medical Associates
  • Stratogen Health of Palm Beach
  • Ctr for Quality Care
  • Univ of South Florida
  • Infectious Disease Research Institute Inc
  • Treasure Coast Infectious Disease Consultants
  • AIDS Research Consortium of Atlanta
  • Infectious Disease Specialists of Atlanta
  • Northwestern Univ Med Ctr
  • SIU School of Medicine
  • Carle Clinic Association
  • Indiana Univ Hosp
  • Univ of Kentucky / Kentucky Clinic Annex #
  • Community Research Initiative
  • Univ of Massachusetts Med Ctr
  • Harper Hosp
  • Saint Joseph's / Mercy Hosp
  • Abbott Northwestern Hosp
  • Mayo Clinic
  • Univ of Missouri at Kansas City School of Medicine
  • Antibiotic Research Associates
  • HIV Wellness Ctr / Univ Med Ctr
  • Dartmouth-Hitchcock Med Ctr
  • UMDNJ - New Jersey Med School / Cooper Hosp
  • VAMC New Jersey Healthcare System
  • New Jersey Community Research Initiative
  • St Joseph's Hosp & Med Center
  • Albany Med College / Division of HIV Medicine A158
  • Montefiore Med Ctr
  • Brookdale Univ Med Ctr
  • Roswell Park Cancer Institute
  • Nassau County Med Ctr
  • Elmhurst Hosp
  • North Shore Univ Hosp
  • Mt Vernon Hosp
  • Dr Michael Mullen
  • Peter Krueger Clinic
  • Howard Grossman
  • AIDS Clinical Trials Unit
  • Dr Douglas Dieterich
  • Dr Ron Grossman
  • Liberty Med Group
  • St Lukes / Roosevelt Hosp / HIV Center
  • New York / Cornell Med Ctr
  • New York Hosp - Cornell Med Ctr
  • New York Hosp / Cornell Med Ctr
  • Harlem Hosp Ctr
  • Carolinas Research Associates
  • Nalle Clinic
  • East Carolina Univ School of Medicine
  • Bowman Gray School of Medicine
  • Univ of Cincinnati Med Ctr / Holmes Division
  • Oklahoma Univ Health Science Ctr
  • Lehigh Valley Hosp
  • Allegheny Univ Hosp
  • Dr Jay Kostman
  • Roger Williams Med Ctr
  • Burnside Clinic
  • Austin Infectious Disease Consultants
  • Dr Nicholaos Bellos
  • Univ of Texas Southwestern Med Ctr of Dallas
  • North Texas Infectious Disease Consultants
  • Houston Clinical Research Network
  • ONCOL Med Associates / PA
  • Houston Med Ctr
  • Houston Clinical Research Network
  • Infectious Disease Physicians Inc
  • Swedish Med Ctr / Dr Peter Shalit
  • Aurora Med Group
  • Medizinische Einrichtungen der Heinrich U
  • Ospedale S Raffaele
  • San Juan Veterans Administration Med Ctr
  • Hosp Valle D Hebron
  • Royal Liverpool Univ Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002378
Brief Title
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

2. Study Status

Record Verification Date
December 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
825 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Delavirdine mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
ASC Inc
City
Aniston
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
Facility Name
CIGNA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Clinical Research Ctr Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Univ of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Med Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Ctr for Special Immunology
City
Irving
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
AIDS Healthcare Foundation Labs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Beer Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Dr Charles Farthing
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gottlieb Med Group
City
North Hollywood
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Dr Wilbert Jordan
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Dr Daniel Pearce
City
San Francisco
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
QUEST Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Marin County Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Shared Med Research Foundation
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Denver Public Health Dept / Disease Control Services
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Kaiser Permanente, Infectious Disease
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Anderson Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Providence Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Urgent Care Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Stratogen of Ft Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Dr Robert Schwartz
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Duval County Health Dept
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Stratogen Health of Palm Beach
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Ctr for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern Univ Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Univ of Kentucky / Kentucky Clinic Annex #
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Community Research Initiative
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint Joseph's / Mercy Hosp
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Abbott Northwestern Hosp
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Antibiotic Research Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
HIV Wellness Ctr / Univ Med Ctr
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Dartmouth-Hitchcock Med Ctr
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
UMDNJ - New Jersey Med School / Cooper Hosp
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
VAMC New Jersey Healthcare System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
New Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
St Joseph's Hosp & Med Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Albany Med College / Division of HIV Medicine A158
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Montefiore Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Brookdale Univ Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Nassau County Med Ctr
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
Elmhurst Hosp
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
North Shore Univ Hosp
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mt Vernon Hosp
City
Mt. Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Dr Michael Mullen
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Peter Krueger Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
AIDS Clinical Trials Unit
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Dr Douglas Dieterich
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Dr Ron Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Liberty Med Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St Lukes / Roosevelt Hosp / HIV Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York / Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Hosp / Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Carolinas Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
East Carolina Univ School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Bowman Gray School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Univ of Cincinnati Med Ctr / Holmes Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Oklahoma Univ Health Science Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lehigh Valley Hosp
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Allegheny Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Dr Jay Kostman
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Austin Infectious Disease Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Dr Nicholaos Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
North Texas Infectious Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
ONCOL Med Associates / PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Houston Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Swedish Med Ctr / Dr Peter Shalit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Aurora Med Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
Medizinische Einrichtungen der Heinrich U
City
Duesseldorf
Country
Germany
Facility Name
Ospedale S Raffaele
City
Milano
Country
Italy
Facility Name
San Juan Veterans Administration Med Ctr
City
San Juan
ZIP/Postal Code
009275800
Country
Puerto Rico
Facility Name
Hosp Valle D Hebron
City
Barcelona
Country
Spain
Facility Name
Royal Liverpool Univ Hosp
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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