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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002378 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Delavirdine mesylate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety 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 |
| Estimated Enrollment: | 825 |
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.
Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Required:
(Note:
Allowed:
AS PER AMENDMENT 12/12/97:
Required:
NRTI experienced patients:
Required:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| ASC Inc | |
| Aniston, Alabama, United States, 36201 | |
| United States, Arizona | |
| CIGNA | |
| Phoenix, Arizona, United States, 85006 | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| Univ of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Marin County Specialty Clinic | |
| San Rafael, California, United States, 94903 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| AIDS Healthcare Foundation Labs | |
| Los Angeles, California, United States, 90027 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| QUEST Clinical Research | |
| San Francisco, California, United States, 94115 | |
| Dr Charles Farthing | |
| Los Angeles, California, United States, 90048 | |
| Shared Med Research Foundation | |
| Tarzana, California, United States, 91356 | |
| Beer Med Group | |
| Los Angeles, California, United States, 90036 | |
| Alta Bates Med Ctr | |
| Berkeley, California, United States, 94705 | |
| Ctr for Special Immunology | |
| Irving, California, United States, 92718 | |
| Gottlieb Med Group | |
| North Hollywood, California, United States, 91607 | |
| Dr Wilbert Jordan | |
| Paramount, California, United States, 90723 | |
| Dr Daniel Pearce | |
| San Francisco, California, United States, 92101 | |
| United States, Colorado | |
| Denver Public Health Dept / Disease Control Services | |
| Denver, Colorado, United States, 80204 | |
| Kaiser Permanente, Infectious Disease | |
| Denver, Colorado, United States, 80205 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Anderson Clinical Research | |
| Washington, District of Columbia, United States, 20037 | |
| Providence Hosp | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| Stratogen of Ft Lauderdale | |
| Fort Lauderdale, Florida, United States, 33334 | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Dr Robert Schwartz | |
| Fort Myers, Florida, United States, 33901 | |
| Stratogen Health of Palm Beach | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| Ctr for Quality Care | |
| Tampa, Florida, United States, 33609 | |
| Duval County Health Dept | |
| Jacksonville, Florida, United States, 32206 | |
| Urgent Care Ctr | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Infectious Disease Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Northwestern Univ Med Ctr | |
| Chicago, Illinois, United States, 60611 | |
| SIU School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| Carle Clinic Association | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Kentucky | |
| Univ of Kentucky / Kentucky Clinic Annex # | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| Community Research Initiative | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Michigan | |
| Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| Saint Joseph's / Mercy Hosp | |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Minnesota | |
| Abbott Northwestern Hosp | |
| Minneapolis, Minnesota, United States, 55407 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| Antibiotic Research Associates | |
| Kansas City, Missouri, United States, 64132 | |
| United States, Nevada | |
| HIV Wellness Ctr / Univ Med Ctr | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Med Ctr | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| UMDNJ - New Jersey Med School / Cooper Hosp | |
| Camden, New Jersey, United States, 08103 | |
| New Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 07103 | |
| VAMC New Jersey Healthcare System | |
| East Orange, New Jersey, United States, 07018 | |
| St Joseph's Hosp & Med Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New York | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| Dr Douglas Dieterich | |
| New York, New York, United States, 10016 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Liberty Med Group | |
| New York, New York, United States, 10016 | |
| New York Hosp / Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| New York Hosp - Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| Mt Vernon Hosp | |
| Mt. Vernon, New York, United States, 10550 | |
| Howard Grossman | |
| New York, New York, United States, 10011 | |
| Dr Ron Grossman | |
| New York, New York, United States, 10016 | |
| AIDS Clinical Trials Unit | |
| New York, New York, United States, 10016 | |
| Elmhurst Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Montefiore Med Ctr | |
| Bronx, New York, United States, 10467 | |
| Brookdale Univ Med Ctr | |
| Brooklyn, New York, United States, 11212 | |
| Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Dr Michael Mullen | |
| New York, New York, United States, 10003 | |
| New York / Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| St Lukes / Roosevelt Hosp / HIV Center | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| East Carolina Univ School of Medicine | |
| Greenville, North Carolina, United States, 27858 | |
| Bowman Gray School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| Carolinas Research Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Univ of Cincinnati Med Ctr / Holmes Division | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Oklahoma | |
| Oklahoma Univ Health Science Ctr | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Dr Jay Kostman | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Lehigh Valley Hosp | |
| Allentown, Pennsylvania, United States, 18105 | |
| Allegheny Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| United States, Rhode Island | |
| Roger Williams Med Ctr | |
| Providence, Rhode Island, United States, 02908 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Texas | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77004 | |
| Houston Med Ctr | |
| Houston, Texas, United States, 77030 | |
| ONCOL Med Associates / PA | |
| Houston, Texas, United States, 77027 | |
| Austin Infectious Disease Consultants | |
| Austin, Texas, United States, 78705 | |
| Dr Nicholaos Bellos | |
| Dallas, Texas, United States, 75225 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77098 | |
| North Texas Infectious Disease Consultants | |
| Dallas, Texas, United States, 75246 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| United States, Washington | |
| Swedish Med Ctr / Dr Peter Shalit | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Aurora Med Group | |
| Milwaukee, Wisconsin, United States, 53212 | |
| Germany | |
| Medizinische Einrichtungen der Heinrich U | |
| Duesseldorf, Germany | |
| Italy | |
| Ospedale S Raffaele | |
| Milano, Italy | |
| Puerto Rico | |
| San Juan Veterans Administration Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
| Spain | |
| Hosp Valle D Hebron | |
| Barcelona, Spain | |
| United Kingdom | |
| Royal Liverpool Univ Hosp | |
| Liverpool, United Kingdom | |
More Information
| Study ID Numbers: | 229H, NR15520, M6101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002378 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Lamivudine Delavirdine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir |
Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir |
