A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the
first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.
However, AZT therapy has been associated with significant toxicities. In addition, the
effectiveness of AZT appears to decrease during the second and third years of therapy. For
these reasons, the development of alternative therapy that would be at least as effective
but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits
replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains
active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low
frequency of drug administration.
Two dose levels of ddI, each adjusted depending on patient's weight at study entry, are
compared with a variable dosage regimen of AZT (the dose which the patient is tolerating at
the time of study entry). Randomization is stratified by baseline CD4 cell count (less than
100 or 100-300) and Medical Center. This study continues for at least 12 months after the
entry of the first subject. Patients randomized to AZT will receive orally. All patients
randomized to AZT also receive a ddI placebo at 12 hour intervals. Patients randomized to
ddI receive AZT placebo.
Interventional
Masking: Double-Blind, Primary Purpose: Treatment
J Kahn
Study Chair
United States: Federal Government
ACTG 117
NCT00000671
Name | Location |
---|---|
Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles, California 900276016 |
Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
Saint Luke's - Roosevelt Hosp Ctr | New York, New York 10025 |
Univ of Rochester Medical Center | Rochester, New York 14642 |
Julio Arroyo | West Columbia, South Carolina 29169 |
Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
Cedars Sinai / UCLA Med Ctr | Los Angeles, California 900481804 |
UCLA CARE Ctr | Los Angeles, California 90095 |
Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles, California 905022004 |
Palo Alto Veterans Adm Med Ctr / Stanford Univ | Palo Alto, California 94304 |
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 |
Stanford Univ School of Medicine | Stanford, California 94305 |
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr | Sylmar, California 91342 |
Olive View Med Ctr | Sylmar, California 91342 |
Harbor UCLA Med Ctr | Torrance, California 90502 |
Univ of Colorado Health Sciences Ctr | Denver, Colorado 80262 |
Mountain States Regional Hemophilia Ctr / Univ of Colorado | Denver, Colorado 80262 |
George Washington Univ Med Ctr | Washington, District of Columbia 20037 |
G E Morey Jr | Fort Lauderdale, Florida 33316 |
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 |
Edward Hines Veterans Administration Hosp | Hines, Illinois 60141 |
Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
Univ of Kansas School of Medicine | Wichita, Kansas 67214 |
Louisiana State Univ Med Ctr / Tulane Med School | New Orleans, Louisiana 70112 |
Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
Louisiana Comprehensive Hemophilia Care Ctr | New Orleans, Louisiana 70112 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
Beth Israel Deaconess Med Ctr | Boston, Massachusetts 02215 |
Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
Boston Med Ctr | Boston, Massachusetts 02118 |
Baystate Med Ctr of Springfield | Springfield, Massachusetts 01199 |
Univ of Massachusetts Med Ctr | Worcester, Massachusetts 01655 |
Med Ctr of Central Massachusetts | Worcester, Massachusetts 01605 |
Univ of Minnesota | Minneapolis, Minnesota 55455 |
Nebraska Regional Hemophilia Ctr | Omaha, Nebraska 68105 |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx, New York 10461 |
Jack Weiler Hosp / Bronx Municipal Hosp | Bronx, New York 10465 |
Bronx Veterans Administration / Mount Sinai Hosp | Bronx, New York 10468 |
Montefiore Med Ctr / Bronx Municipal Hosp | Bronx, New York 10467 |
SUNY / Erie County Med Ctr at Buffalo | Buffalo, New York 14215 |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst, New York 11373 |
Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr | New York, New York 10029 |
Cornell Univ Med Ctr | New York, New York 10021 |
Mount Sinai Med Ctr | New York, New York 10029 |
Beth Israel Med Ctr / Peter Krueger Clinic | New York, New York 10003 |
SUNY - Stony Brook | Stony Brook, New York 117948153 |
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 |
Bowman Gray School of Medicine / Wake Forest Univ | Winston-Salem, North Carolina 27103 |
Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati, Ohio 452670405 |
Univ Hosp of Cleveland / Case Western Reserve Univ | Cleveland, Ohio 44106 |
Ohio State Univ Hosp Clinic | Columbus, Ohio 432101228 |
Med College of Ohio | Toledo, Ohio 43699 |
Milton S Hershey Med Ctr | Hershey, Pennsylvania 170330850 |
Univ of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Hemophilia Ctr of Western PA / Univ of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
Univ of Pittsburgh Med School | Pittsburgh, Pennsylvania |
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville, Tennessee 37920 |
Hermann Hosp / Univ Texas Health Science Ctr | Houston, Texas 77030 |
Dr Stephen L Green | Hampton, Virginia 23666 |
Univ of Washington | Seattle, Washington 98105 |
Great Lakes Hemophilia Foundation | Milwaukee, Wisconsin 53233 |
Dr Brian Buggy | Milwaukee, Wisconsin 53215 |
Milwaukee County Med Complex | Milwaukee, Wisconsin 53226 |