HIV InfectionsPhase 3NCT00002378
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
A Phase 3 study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 102 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Nelfinavir mesylate and Saquinavir
- How many people
- 825 participants
- Where
- 102 sitesin 6 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 24Show fewer
- (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.
Who cannot join
None listed.
Trial locations and contacts
102 sites in 6 countries.
102 sites in 6 countries
United States97 sites
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105
IDC Research Initiative
Altamonte Springs, Florida, 32701
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
ASC Inc
Anniston, Alabama, 36201
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Austin Infectious Disease Consultants
Austin, Texas, 78705
Alta Bates Med Ctr
Berkeley, California, 94705
Community Research Initiative
Brookline, Massachusetts, 02445
Brookdale Univ Med Ctr
Brooklyn, New York, 11212
Roswell Park Cancer Institute
Buffalo, New York, 14263
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103
Carolinas Research Associates
Charlotte, North Carolina, 28203
Nalle Clinic
Charlotte, North Carolina, 28207
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, 45267
Burnside Clinic
Columbia, South Carolina, 29206
Dr Nicholaos Bellos
Dallas, Texas, 75225
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Denver Public Health Dept / Disease Control Services
Denver, Colorado, 80204
Kaiser Permanente, Infectious Disease
Denver, Colorado, 80205
Harper Hosp
Detroit, Michigan, 48201
Nassau County Med Ctr
East Meadow, New York, 11554
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
Elmhurst Hosp
Elmhurst, New York, 11373
Urgent Care Ctr
Fort Lauderdale, Florida, 33316
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, 33334
Dr Robert Schwartz
Fort Myers, Florida, 33901
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858
Houston Clinical Research Network
Houston, Texas, 77004
ONCOL Med Associates / PA
Houston, Texas, 77027
Houston Med Ctr
Houston, Texas, 77030
Houston Clinical Research Network
Houston, Texas, 77098
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Ctr for Special Immunology
Irvington District, California, 92718
Duval County Health Dept
Jacksonville, Florida, 32206
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Antibiotic Research Associates
Kansas City, Missouri, 64132
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756
Univ of Kentucky / Kentucky Clinic Annex #
Lexington, Kentucky, 40536
AIDS Healthcare Foundation Labs
Los Angeles, California, 90027
Beer Med Group
Los Angeles, California, 90036
Dr Charles Farthing
Los Angeles, California, 90048
North Shore Univ Hosp
Manhasset, New York, 11030
Steinhart Medical Associates
Miami, Florida, 33133
Aurora Med Group
Milwaukee, Wisconsin, 53212
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407
Mt Vernon Hosp
Mount Vernon, New York, 10550
Dr Michael Mullen
New York, New York, 10003
Peter Krueger Clinic
New York, New York, 10003
Howard Grossman
New York, New York, 10011
AIDS Clinical Trials Unit
New York, New York, 10016
Dr Douglas Dieterich
New York, New York, 10016
Dr Ron Grossman
New York, New York, 10016
Liberty Med Group
New York, New York, 10016
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019
New York / Cornell Med Ctr
New York, New York, 10021
New York Hosp - Cornell Med Ctr
New York, New York, 10021
New York Hosp / Cornell Med Ctr
New York, New York, 10021
Harlem Hosp Ctr
New York, New York, 10037
New Jersey Community Research Initiative
Newark, New Jersey, 07103
Gottlieb Med Group
North Hollywood, California, 91607
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104
Stratogen Health of Palm Beach
Palm Beach Gardens, Florida, 33410
Dr Wilbert Jordan
Paramount, California, 90723
St Joseph's Hosp & Med Center
Paterson, New Jersey, 07503
Allegheny Univ Hosp
Philadelphia, Pennsylvania, 19129
Dr Jay Kostman
Philadelphia, Pennsylvania, 19140
CIGNA
Phoenix, Arizona, 85006
Roger Williams Med Ctr
Providence, Rhode Island, 02908
AIDS Community Research Consortium
Redwood City, California, 94063
Mayo Clinic
Rochester, Minnesota, 55905
Dr Daniel Pearce
San Francisco, California, 92101
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Permanente Med Ctr
San Francisco, California, 94115
QUEST Clinical Research
San Francisco, California, 94115
Marin County Specialty Clinic
San Rafael, California, 94903
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, 98104
SIU School of Medicine
Springfield, Illinois, 62702
Ctr for Quality Care
Tampa, Florida, 33609
Univ of South Florida
Tampa, Florida, 33612
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Shared Med Research Foundation
Tarzana, California, 91356
Montefiore Med Ctr
The Bronx, New York, 10467
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
Univ of Arizona
Tucson, Arizona, 85724
Carle Clinic Association
Urbana, Illinois, 61801
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Anderson Clinical Research
Washington D.C., District of Columbia, 20037
Providence Hosp
Washington D.C., District of Columbia, 20037
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 27157
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
Saint Joseph's / Mercy Hosp
Ypsilanti, Michigan, 48197
Puerto Rico1 site
San Juan Veterans Administration Med Ctr
San Juan, 009275800
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Nelfinavir mesylate, Saquinavir, Delavirdine mesylate, Lamivudine
- 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
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Nelfinavir mesylateDrug
SaquinavirDrug
Delavirdine mesylateDrug
LamivudineDrug
StavudineDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 825 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002378
- Sponsor's protocol ID
- 229H
- Other IDs
- NR15520, M6101
- Status last verified
- Dec 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No