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
16 Years
N/A
Both
HIV Infections
Trial Information
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
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
229H
NCT ID:
NCT00002378
Start Date:
Completion Date:
Related Keywords:
- HIV Infections
- 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
- HIV Infections
- Acquired Immunodeficiency Syndrome
Name | Location |
|---|---|
| Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
| Univ of Massachusetts Med Ctr | Worcester, Massachusetts 01655 |
| Univ of South Florida | Tampa, Florida 33612 |
| Georgetown Univ Med Ctr | Washington, District of Columbia 20007 |
| Albany Med College / Division of HIV Medicine A158 | Albany, New York 122083479 |
| North Shore Univ Hosp | Manhasset, New York 11030 |
| Harlem Hosp Ctr | New York, New York 10037 |
| AIDS Research Consortium of Atlanta | Atlanta, Georgia 30308 |
| New Jersey Community Research Initiative | Newark, New Jersey 07103 |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas, Texas 75235 |
| Marin County Specialty Clinic | San Rafael, California 94903 |
| Ctr for Special Immunology | Irvine, California 92718 |
| Univ of Missouri at Kansas City School of Medicine | Kansas City, Missouri 64108 |
| Nassau County Med Ctr | East Meadow, New York 11554 |
| Houston Clinical Research Network | Houston, Texas 77266 |
| Gottlieb Med Group | Sherman Oaks, California 91403 |
| Dr Douglas Dieterich | New York, New York 10016 |
| Infectious Disease Physicians Inc | Annandale, Virginia 22203 |
| Lehigh Valley Hosp | Allentown, Pennsylvania 18104 |
| Harper Hosp | Detroit, Michigan 48201 |
| Kaiser Permanente Med Ctr | San Francisco, California 94115 |
| UCSF - San Francisco Gen Hosp | San Francisco, California 94110 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| UMDNJ - New Jersey Med School / Cooper Hosp | Camden, New Jersey 08103 |
| ASC Inc | Aniston, Alabama 36201 |
| CIGNA | Phoenix, Arizona 85006 |
| Arizona Clinical Research Ctr Inc | Tucson, Arizona 85712 |
| Univ of Arizona | Tucson, Arizona 85724 |
| Alta Bates Med Ctr | Berkeley, California 94705 |
| Beer Med Group | Los Angeles, California 90036 |
| AIDS Healthcare Foundation Labs | Los Angeles, California 90027 |
| Dr Charles Farthing | Los Angeles, California 90048 |
| Dr Wilbert Jordan | Paramount, California 90723 |
| AIDS Community Research Consortium | Redwood City, California 94063 |
| Dr Daniel Pearce | San Francisco, California 92101 |
| QUEST Clinical Research | San Francisco, California 94115 |
| Shared Med Research Foundation | Tarzana, California 91356 |
| Denver Public Health Dept / Disease Control Services | Denver, Colorado 80204 |
| Kaiser Permanente, Infectious Disease | Denver, Colorado 80205 |
| Anderson Clinical Research | Washington, District of Columbia 20037 |
| Providence Hosp | Washington, District of Columbia 20037 |
| IDC Research Initiative | Altamonte Springs, Florida 32701 |
| Stratogen of Ft Lauderdale | Fort Lauderdale, Florida 33334 |
| Urgent Care Ctr | Fort Lauderdale, Florida 33316 |
| Dr Robert Schwartz | Fort Myers, Florida 33901 |
| Duval County Health Dept | Jacksonville, Florida 32206 |
| Steinhart Medical Associates | Miami, Florida 33133 |
| Stratogen Health of Palm Beach | Palm Beach Gardens, Florida 33410 |
| Ctr for Quality Care | Tampa, Florida 33609 |
| Infectious Disease Research Institute Inc | Tampa, Florida 33614 |
| Treasure Coast Infectious Disease Consultants | Vero Beach, Florida 32960 |
| Infectious Disease Specialists of Atlanta | Decatur, Georgia 30033 |
| Northwestern Univ Med Ctr | Chicago, Illinois 60611 |
| SIU School of Medicine | Springfield, Illinois 62702 |
| Carle Clinic Association | Urbana, Illinois 61801 |
| Univ of Kentucky / Kentucky Clinic Annex # | Lexington, Kentucky 40536 |
| Community Research Initiative | Brookline, Massachusetts 02445 |
| Saint Joseph's / Mercy Hosp | Ypsilanti, Michigan 48197 |
| Abbott Northwestern Hosp | Minneapolis, Minnesota 55407 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| 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 |
| VAMC New Jersey Healthcare System | East Orange, New Jersey 07018 |
| St Joseph's Hosp & Med Center | Paterson, New Jersey 07503 |
| Montefiore Med Ctr | Bronx, New York 10467 |
| Brookdale Univ Med Ctr | Brooklyn, New York 11212 |
| Elmhurst Hosp | Elmhurst, New York 11373 |
| Mt Vernon Hosp | Mt. Vernon, New York 10550 |
| New York Hosp - Cornell Med Ctr | New York, New York 10021 |
| Dr Ron Grossman | New York, New York 10016 |
| AIDS Clinical Trials Unit | New York, New York 10016 |
| New York Hosp / Cornell Med Ctr | New York, New York 10021 |
| Liberty Med Group | New York, New York 10016 |
| Howard Grossman | New York, New York 10011 |
| Peter Krueger Clinic | New York, New York 10003 |
| Dr Michael Mullen | New York, New York 10003 |
| New York / Cornell Med Ctr | New York, New York 10021 |
| St Lukes / Roosevelt Hosp / HIV Center | New York, New York 10019 |
| Nalle Clinic | Charlotte, North Carolina 28207 |
| Carolinas Research Associates | Charlotte, North Carolina 28203 |
| East Carolina Univ School of Medicine | Greenville, North Carolina 27858 |
| Bowman Gray School of Medicine | Winston Salem, North Carolina 27157 |
| Univ of Cincinnati Med Ctr / Holmes Division | Cincinnati, Ohio 45267 |
| Oklahoma Univ Health Science Ctr | Oklahoma City, Oklahoma 73104 |
| Allegheny Univ Hosp | Philadelphia, Pennsylvania 19129 |
| Dr Jay Kostman | Philadelphia, Pennsylvania 19140 |
| Roger Williams Med Ctr | Providence, Rhode Island 02908 |
| Burnside Clinic | Columbia, South Carolina 29206 |
| Austin Infectious Disease Consultants | Austin, Texas 78705 |
| Dr Nicholaos Bellos | Dallas, Texas 75225 |
| North Texas Infectious Disease Consultants | Dallas, Texas 75246 |
| ONCOL Med Associates / PA | Houston, Texas 77027 |
| Houston Med Ctr | Houston, Texas 77030 |
| Swedish Med Ctr / Dr Peter Shalit | Seattle, Washington 98104 |
| Aurora Med Group | Milwaukee, Wisconsin 53212 |
