A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus
agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study
will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and
whether AZT therapy will delay the development of opportunistic infections and/or KS
lesions.
Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day,
and the second receiving AZT for 3 doses per day. A placebo group is divided into two to
match the two treatment groups. Study patients are stratified according to whether they have
(a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous
lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2
months, every other week for the next 2 months, and monthly thereafter.
Interventional
Masking: Double-Blind, Primary Purpose: Treatment
Valentine FT
Study Chair
United States: Food and Drug Administration
ACTG 001
NCT00000994
May 1990
Name | Location |
---|---|
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 |
Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
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 |
Stanford Univ School of Medicine | Stanford, California 94305 |
Louisiana State Univ Med Ctr / Tulane Med School | New Orleans, Louisiana 70112 |
Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
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 |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst, New York 11373 |
Mount Sinai Med Ctr | New York, New York 10029 |
Beth Israel Med Ctr / Peter Krueger Clinic | New York, New York 10003 |
SUNY / State Univ of New York | Syracuse, New York 13210 |
Duke Univ Med Ctr | Durham, North Carolina 27710 |
Johns Hopkins Hosp | Baltimore, Maryland 21287 |
Charity Hosp / Tulane Univ Med School | New Orleans, Louisiana 70112 |