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.]
Interventional
Primary Purpose: Treatment
Hammer SM
Study Chair
United States: Federal Government
ACTG 320
NCT00000841
June 1997
Name | Location |
---|---|
San Francisco Gen Hosp | San Francisco, California 941102859 |
Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
Univ of Rochester Medical Center | Rochester, New York 14642 |
Julio Arroyo | West Columbia, South Carolina 29169 |
UCLA CARE Ctr | Los Angeles, California 90095 |
Univ of California / San Diego Treatment Ctr | San Diego, California 921036325 |
San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco, California 941102859 |
Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco, California 94115 |
Harbor UCLA Med Ctr | Torrance, California 90502 |
Univ of Colorado Health Sciences Ctr | Denver, Colorado 80262 |
Univ of Miami School of Medicine | Miami, Florida 331361013 |
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois 60612 |
Northwestern Univ Med School | Chicago, Illinois 60611 |
Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
Boston Med Ctr | Boston, Massachusetts 02118 |
Univ of Minnesota | Minneapolis, Minnesota 55455 |
Bronx Veterans Administration / Mount Sinai Hosp | Bronx, New York 10468 |
SUNY / Erie County Med Ctr at Buffalo | Buffalo, New York 14215 |
Cornell Univ Med Ctr | New York, New York 10021 |
Mount Sinai Med Ctr | New York, New York 10029 |
SUNY / State Univ of New York | Syracuse, New York 13210 |
Univ of North Carolina | Chapel Hill, North Carolina 275997215 |
Duke Univ Med Ctr | Durham, North Carolina 27710 |
Ohio State Univ Hosp Clinic | Columbus, Ohio 432101228 |
Milton S Hershey Med Ctr | Hershey, Pennsylvania 170330850 |
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville, Tennessee 37920 |
Univ of Washington | Seattle, Washington 98105 |
Great Lakes Hemophilia Foundation | Milwaukee, Wisconsin 53233 |
Johns Hopkins Hosp | Baltimore, Maryland 21287 |
Charity Hosp / Tulane Univ Med School | New Orleans, Louisiana 70112 |
St Louis Regional Hosp / St Louis Regional Med Ctr | St Louis, Missouri 63112 |
Columbus Children's Hosp | Columbus, Ohio 432052696 |
Univ of Alabama at Birmingham | Birmingham, Alabama 35294 |
Univ of Southern California / LA County USC Med Ctr | Los Angeles, California 900331079 |
Univ of Iowa Hosp and Clinic | Iowa City, Iowa 52242 |
Hennepin County Med Clinic | Minneapolis, Minnesota 55415 |
St Paul Ramsey Med Ctr | St Paul, Minnesota 55101 |
Univ of Nebraska Med Ctr | Omaha, Nebraska 681985130 |
Beth Israel Med Ctr | New York, New York 10003 |
Saint Clare's Hosp and Health Ctr | New York, New York 10019 |
Carolinas Med Ctr | Charlotte, North Carolina 28203 |
Moses H Cone Memorial Hosp | Greensboro, North Carolina 27401 |
Univ of Cincinnati | Cincinnati, Ohio 452670405 |
Thomas Jefferson Univ Hosp | Philadelphia, Pennsylvania 191075098 |
Children's Hosp of Los Angeles | Los Angeles, California 90027 |
Stanford Univ Med Ctr | Stanford, California 943055107 |
San Mateo AIDS Program / Stanford Univ | Stanford, California 943055107 |
Mountain States Reg Hemo Ctr / Univ of Colorado | Denver, Colorado 80262 |
Howard Univ | Washington, District of Columbia 20059 |
George Washington Univ / Hershey Med Ctr | Washington, District of Columbia 20037 |
Univ of Hawaii | Honolulu, Hawaii 96816 |
Louis A Weiss Memorial Hosp | Chicago, Illinois 60640 |
Methodist Hosp of Indiana / Life Care Clinic | Indianapolis, Indiana 46202 |
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | Worcester, Massachusetts 01605 |
Montefiore Med Ctr Adolescent AIDS Program | Bronx, New York 10467 |
North Shore Univ Hosp | Manhasset, New York 11030 |
Mount Sinai Med Ctr / Hemophilia Treatment Ctr | New York, New York 10029 |
Harlem Hosp Ctr | New York, New York 10037 |
Univ of Kentucky Lexington | Cincinnati, Ohio 45267 |
Case Western Reserve Univ | Cleveland, Ohio 44106 |
Meharry Med College | Nashville, Tennessee 37203 |
Univ of Texas Galveston | Galveston, Texas 775550435 |
Univ Texas Health Science Ctr / Univ Texas Med School | Houston, Texas 77030 |
Queens Med Ctr | Honolulu, Hawaii 96816 |
Illinois Masonic Med Ctr | Chicago, Illinois 606575147 |
Mount Sinai Med Ctr / Pediatrics | New York, New York 10029 |
Kaiser Permanente Franklin Med Ctr | Denver, Colorado 80262 |
Georgetown Univ Hosp | Washington, District of Columbia 20037 |
Univ of Miami (Pediatric) | Miami, Florida 33161 |
Emory Univ | Atlanta, Georgia 30308 |
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | Atlanta, Georgia 303652225 |
Chicago Children's Memorial Hosp | Chicago, Illinois 606143394 |
Division of Inf Diseases/ Indiana Univ Hosp | Indianapolis, Indiana 46202 |
Tulane Med Ctr Hosp | New Orleans, Louisiana 70112 |
State of MD Div of Corrections / Johns Hopkins Univ Hosp | Baltimore, Maryland 212052196 |
Manhattan Veterans Administration / New York Univ Med Ctr | New York, New York 10016 |
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr | New York, New York 10021 |
Kaplan Cancer Ctr / New York Univ Med Ctr | New York, New York 10016 |
Central Prison/Women's Prison in Raleigh / NC | Raleigh, North Carolina 276260540 |
Med Univ of South Carolina | Charleston, South Carolina 294253312 |
Vanderbilt Univ Med Ctr | Nashville, Tennessee 37203 |