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A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience


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

Thank you

Trial Information

A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience


Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV
disease who have received prior AZT therapy. Since studies suggest that triple drug therapy
may have an advantage over both monotherapy and two drug therapy, the combination of
indinavir sulfate with AZT and 3TC should be evaluated.

Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate
for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease
after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at
weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. [AS PER
02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple
therapy superior to double-agent therapy. An open label extension phase has been added for
the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the
option of continuing on assigned ACTG 320 study drugs, crossing over to open-label
indinavir, or permanently discontinuing all study therapies and going off study. Patients
who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given
the option of continuing their currently assigned therapies. It is strongly suggested that
patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the
nucleoside analog component of their regimen if at all possible.] [ AS PER 06/06/97
AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for
approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow
patients to continue receiving study medications until ACTG 372 is open to accrual (the
rollover protocol for subjects originally randomized to the triple drug component of ACTG
320 or who are crossed over due to a confirmed study endpoint is finalized).] [ AS PER
09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the
enrollment of the first subject on ACTG 372.]

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Required:

- PCP prophylaxis.

Allowed:

- Topical or oral antifungal agents (other than oral ketoconazole).

- Approved agents for opportunistic infections.

- Antibiotics unless specifically excluded.

- Systemic corticosteroids for no more than 21 days.

- Vitamins.

- Recombinant erythropoietin.

- G-CSF.

- Regularly prescribed medications such as allergy medications, antidepressants,
antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.

Concurrent Treatment:

Allowed:

- Acupuncture.

- Visualization techniques.

Patients must have:

- HIV infection.

- CD4 count <= 200 cells/mm3.

- At least 6 months total prior AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.

Concurrent Medication:

Excluded:

- Antiretrovirals other than study drugs.

- Rifabutin and rifampin.

- Investigational drugs other than indinavir sulfate.

- Systemic cytotoxic chemotherapy.

- Oral ketoconazole.

- Chronic systemic corticosteroids.

- Herbal therapies.

Patients with the following prior conditions are excluded:

- Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.

- Chronic diarrhea persisting for 15 days within 30 days prior to study entry.

- History of acute or chronic pancreatitis.

- Acute hepatitis within 30 days prior to study entry.

- Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.

- Dose-limiting intolerance to prior AZT at 600 mg/day.

Prior Medication:

Excluded:

- More than 1 week of prior 3TC.

- Any prior protease inhibitors.

- Rifampin or rifabutin within 14 days prior to study entry.

Excluded within 30 days prior to study entry:

- Erythropoietin.

- G-CSF or GM-CSF.

- Non-nucleoside reverse transcriptase inhibitors.

- Interferons.

- Interleukins.

- HIV vaccines.

- Any experimental therapy.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Hammer SM

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 320

NCT ID:

NCT00000841

Start Date:

Completion Date:

June 1997

Related Keywords:

  • HIV Infections
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Antiviral Agents
  • Zidovudine
  • Stavudine
  • HIV Protease Inhibitors
  • Lamivudine
  • Indinavir
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
UCLA CARE CtrLos Angeles, California  90095
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Harbor UCLA Med CtrTorrance, California  90502
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Boston Med CtrBoston, Massachusetts  02118
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
SUNY / State Univ of New YorkSyracuse, New York  13210
Univ of North CarolinaChapel Hill, North Carolina  275997215
Duke Univ Med CtrDurham, North Carolina  27710
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Univ of Tennessee / E Tennessee Comprehensive Hemophilia CtrKnoxville, Tennessee  37920
Univ of WashingtonSeattle, Washington  98105
Great Lakes Hemophilia FoundationMilwaukee, Wisconsin  53233
Johns Hopkins HospBaltimore, Maryland  21287
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Columbus Children's HospColumbus, Ohio  432052696
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Univ of Iowa Hosp and ClinicIowa City, Iowa  52242
Hennepin County Med ClinicMinneapolis, Minnesota  55415
St Paul Ramsey Med CtrSt Paul, Minnesota  55101
Univ of Nebraska Med CtrOmaha, Nebraska  681985130
Beth Israel Med CtrNew York, New York  10003
Saint Clare's Hosp and Health CtrNew York, New York  10019
Carolinas Med CtrCharlotte, North Carolina  28203
Moses H Cone Memorial HospGreensboro, North Carolina  27401
Univ of CincinnatiCincinnati, Ohio  452670405
Thomas Jefferson Univ HospPhiladelphia, Pennsylvania  191075098
Children's Hosp of Los AngelesLos Angeles, California  90027
Stanford Univ Med CtrStanford, California  943055107
San Mateo AIDS Program / Stanford UnivStanford, California  943055107
Mountain States Reg Hemo Ctr / Univ of ColoradoDenver, Colorado  80262
Howard UnivWashington, District of Columbia  20059
George Washington Univ / Hershey Med CtrWashington, District of Columbia  20037
Univ of HawaiiHonolulu, Hawaii  96816
Louis A Weiss Memorial HospChicago, Illinois  60640
Methodist Hosp of Indiana / Life Care ClinicIndianapolis, Indiana  46202
Worcester Memorial Hosp / Med Ctr of Cntrl MA-MemorialWorcester, Massachusetts  01605
Montefiore Med Ctr Adolescent AIDS ProgramBronx, New York  10467
North Shore Univ HospManhasset, New York  11030
Mount Sinai Med Ctr / Hemophilia Treatment CtrNew York, New York  10029
Harlem Hosp CtrNew York, New York  10037
Univ of Kentucky LexingtonCincinnati, Ohio  45267
Case Western Reserve UnivCleveland, Ohio  44106
Meharry Med CollegeNashville, Tennessee  37203
Univ of Texas GalvestonGalveston, Texas  775550435
Univ Texas Health Science Ctr / Univ Texas Med SchoolHouston, Texas  77030
Queens Med CtrHonolulu, Hawaii  96816
Illinois Masonic Med CtrChicago, Illinois  606575147
Mount Sinai Med Ctr / PediatricsNew York, New York  10029
Kaiser Permanente Franklin Med CtrDenver, Colorado  80262
Georgetown Univ HospWashington, District of Columbia  20037
Univ of Miami (Pediatric)Miami, Florida  33161
Emory UnivAtlanta, Georgia  30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo CtrAtlanta, Georgia  303652225
Chicago Children's Memorial HospChicago, Illinois  606143394
Division of Inf Diseases/ Indiana Univ HospIndianapolis, Indiana  46202
Tulane Med Ctr HospNew Orleans, Louisiana  70112
State of MD Div of Corrections / Johns Hopkins Univ HospBaltimore, Maryland  212052196
Manhattan Veterans Administration / New York Univ Med CtrNew York, New York  10016
St Vincent's Hosp / Mem Sloan-Kettering Cancer CtrNew York, New York  10021
Kaplan Cancer Ctr / New York Univ Med CtrNew York, New York  10016
Central Prison/Women's Prison in Raleigh / NCRaleigh, North Carolina  276260540
Med Univ of South CarolinaCharleston, South Carolina  294253312
Vanderbilt Univ Med CtrNashville, Tennessee  37203