Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
Results from several studies show that a high percentage of people infected with HIV will
eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known
to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in
advanced disease, it is reasonable to try it in less advanced cases.
Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo
(inactive medication). Patients take 3 capsules 5 times a day (every 4 hours from 8 am until
12 pm).
The capsules contain either AZT or placebo and are identical in appearance so that neither
patient nor physician knows which treatment the patient is receiving. The higher dose
corresponds to the dose found to be useful in patients with AIDS or severe ARC. Patients
visit the clinic every 2 weeks for the first 16 weeks, then once a month after that for
evaluation. Treatment will continue until the results from the study have been analyzed,
which could be as long as 3 years. If side effects occur, the dose of study medication will
be decreased or temporarily stopped. If the side effects are severe, then study medication
will be stopped permanently.
AMENDED: Effective with Version 4 (900226), dosing for ALL patients on Phase 2 study drug,
regardless of CD4+ substudy, will proceed as open-label AZT. Original treatment assignments
employed in the > 500 cells/mm3 substudy during the period from August 16, 1989 through the
release of this new version. Also, toxicity management and dose modification of AZT for
patients receiving Phase 2 study drug have been changed.
Interventional
Masking: Double-Blind, Primary Purpose: Treatment
Volberding P
Study Chair
United States: Federal Government
ACTG 019
NCT00000736
February 1995
Name | Location |
---|---|
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 |
UCLA CARE Ctr | Los Angeles, California 90095 |
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 |
Harbor UCLA Med Ctr | Torrance, California 90502 |
George Washington Univ Med Ctr | Washington, District of Columbia 20037 |
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois 60612 |
Northwestern Univ Med School | Chicago, Illinois 60611 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
Beth Israel Deaconess Med Ctr | Boston, Massachusetts 02215 |
Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
Univ of Minnesota | Minneapolis, Minnesota 55455 |
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 |
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 |
Duke Univ Med Ctr | Durham, North Carolina 27710 |
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 |
Univ of Pittsburgh Med School | Pittsburgh, Pennsylvania |
Univ of Washington | Seattle, Washington 98105 |
Johns Hopkins Hosp | Baltimore, Maryland 21287 |
Summitt Med Ctr / San Francisco Gen Hosp | Oakland, California 94609 |
Children's Hosp of San Francisco | San Francisco, California 94118 |
San Francisco AIDS Clinic | San Francisco, California 94143 |
St Louis Regional Hosp / St Louis Regional Med Ctr | St Louis, Missouri 63112 |
Columbus Children's Hosp | Columbus, Ohio 432052696 |