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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


Phase 3
16 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

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