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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 HospIndianapolis, Indiana  462025250
Univ of Massachusetts Med CtrWorcester, Massachusetts  01655
Univ of South FloridaTampa, Florida  33612
Georgetown Univ Med CtrWashington, District of Columbia  20007
Albany Med College / Division of HIV Medicine A158Albany, New York  122083479
North Shore Univ HospManhasset, New York  11030
Harlem Hosp CtrNew York, New York  10037
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
New Jersey Community Research InitiativeNewark, New Jersey  07103
Univ of Texas Southwestern Med Ctr of DallasDallas, Texas  75235
Marin County Specialty ClinicSan Rafael, California  94903
Ctr for Special ImmunologyIrvine, California  92718
Univ of Missouri at Kansas City School of MedicineKansas City, Missouri  64108
Nassau County Med CtrEast Meadow, New York  11554
Houston Clinical Research NetworkHouston, Texas  77266
Gottlieb Med GroupSherman Oaks, California  91403
Dr Douglas DieterichNew York, New York  10016
Infectious Disease Physicians IncAnnandale, Virginia  22203
Lehigh Valley HospAllentown, Pennsylvania  18104
Harper HospDetroit, Michigan  48201
Kaiser Permanente Med CtrSan Francisco, California  94115
UCSF - San Francisco Gen HospSan Francisco, California  94110
Roswell Park Cancer InstituteBuffalo, New York  14263
UMDNJ - New Jersey Med School / Cooper HospCamden, New Jersey  08103
ASC IncAniston, Alabama  36201
CIGNAPhoenix, Arizona  85006
Arizona Clinical Research Ctr IncTucson, Arizona  85712
Univ of ArizonaTucson, Arizona  85724
Alta Bates Med CtrBerkeley, California  94705
Beer Med GroupLos Angeles, California  90036
AIDS Healthcare Foundation LabsLos Angeles, California  90027
Dr Charles FarthingLos Angeles, California  90048
Dr Wilbert JordanParamount, California  90723
AIDS Community Research ConsortiumRedwood City, California  94063
Dr Daniel PearceSan Francisco, California  92101
QUEST Clinical ResearchSan Francisco, California  94115
Shared Med Research FoundationTarzana, California  91356
Denver Public Health Dept / Disease Control ServicesDenver, Colorado  80204
Kaiser Permanente, Infectious DiseaseDenver, Colorado  80205
Anderson Clinical ResearchWashington, District of Columbia  20037
Providence HospWashington, District of Columbia  20037
IDC Research InitiativeAltamonte Springs, Florida  32701
Stratogen of Ft LauderdaleFort Lauderdale, Florida  33334
Urgent Care CtrFort Lauderdale, Florida  33316
Dr Robert SchwartzFort Myers, Florida  33901
Duval County Health DeptJacksonville, Florida  32206
Steinhart Medical AssociatesMiami, Florida  33133
Stratogen Health of Palm BeachPalm Beach Gardens, Florida  33410
Ctr for Quality CareTampa, Florida  33609
Infectious Disease Research Institute IncTampa, Florida  33614
Treasure Coast Infectious Disease ConsultantsVero Beach, Florida  32960
Infectious Disease Specialists of AtlantaDecatur, Georgia  30033
Northwestern Univ Med CtrChicago, Illinois  60611
SIU School of MedicineSpringfield, Illinois  62702
Carle Clinic AssociationUrbana, Illinois  61801
Univ of Kentucky / Kentucky Clinic Annex #Lexington, Kentucky  40536
Community Research InitiativeBrookline, Massachusetts  02445
Saint Joseph's / Mercy HospYpsilanti, Michigan  48197
Abbott Northwestern HospMinneapolis, Minnesota  55407
Mayo ClinicRochester, Minnesota  55905
Antibiotic Research AssociatesKansas City, Missouri  64132
HIV Wellness Ctr / Univ Med CtrLas Vegas, Nevada  89102
Dartmouth-Hitchcock Med CtrLebanon, New Hampshire  03756
VAMC New Jersey Healthcare SystemEast Orange, New Jersey  07018
St Joseph's Hosp & Med CenterPaterson, New Jersey  07503
Montefiore Med CtrBronx, New York  10467
Brookdale Univ Med CtrBrooklyn, New York  11212
Elmhurst HospElmhurst, New York  11373
Mt Vernon HospMt. Vernon, New York  10550
New York Hosp - Cornell Med CtrNew York, New York  10021
Dr Ron GrossmanNew York, New York  10016
AIDS Clinical Trials UnitNew York, New York  10016
New York Hosp / Cornell Med CtrNew York, New York  10021
Liberty Med GroupNew York, New York  10016
Howard GrossmanNew York, New York  10011
Peter Krueger ClinicNew York, New York  10003
Dr Michael MullenNew York, New York  10003
New York / Cornell Med CtrNew York, New York  10021
St Lukes / Roosevelt Hosp / HIV CenterNew York, New York  10019
Nalle ClinicCharlotte, North Carolina  28207
Carolinas Research AssociatesCharlotte, North Carolina  28203
East Carolina Univ School of MedicineGreenville, North Carolina  27858
Bowman Gray School of MedicineWinston Salem, North Carolina  27157
Univ of Cincinnati Med Ctr / Holmes DivisionCincinnati, Ohio  45267
Oklahoma Univ Health Science CtrOklahoma City, Oklahoma  73104
Allegheny Univ HospPhiladelphia, Pennsylvania  19129
Dr Jay KostmanPhiladelphia, Pennsylvania  19140
Roger Williams Med CtrProvidence, Rhode Island  02908
Burnside ClinicColumbia, South Carolina  29206
Austin Infectious Disease ConsultantsAustin, Texas  78705
Dr Nicholaos BellosDallas, Texas  75225
North Texas Infectious Disease ConsultantsDallas, Texas  75246
ONCOL Med Associates / PAHouston, Texas  77027
Houston Med CtrHouston, Texas  77030
Swedish Med Ctr / Dr Peter ShalitSeattle, Washington  98104
Aurora Med GroupMilwaukee, Wisconsin  53212