ACTG Highlights

e.g., 281 patients participated in the clinical trial on which FDA approval of AZT was based. Close to
11,000 persons, including asymptomatic and symptomatic HIV-infected individuals, have participated in ACTG
clinical trials.
ACT UP ALLEGES
Only 17 percent of ACTG study participants have been in clinical trials of AIDS-related Ols and cancers.
THE FACTS
Since July 1989, there has been a 300 percent increase in the actual numbers of patients in ACTG studies of
Ols (from 703 to 2065) and the percentage of ACTG participants who have been in 01 studies has more than
doubled (from 10% to 22%). 5.3% of ACTG participants have been enrolled in cancer studies.
ACT UP ALLEGES
A slow-down has occurred in the initiation of new studies because of the change-over of data analysis centers
from Research Triangle Institute to the Statistical and Data Analysis Center, based at Harvard School of
Public Health.
THE FACTS
Untrue. The rate of initiation of new ACTG studies has remained constant throughout the period of the
change-over, which began in September 1989 and is expected to be completed in June of this year.
Approximately 40 new studies were added in 1989. In 1990, approximately 40 new studies are anticipated to
open and 9 studies have already begun.
ACT UP ALLEGES
From one-third to one-half of the ACTG grants are paid to the sites whether or not they enroll a single
patient
THE FACTS
All NIH grants and contracts include funds for overhead costs at awardee institutions. These indirect costs
are linked to the amounts awarded for the costs of conducting studies. It is absolutely untrue that ACTG
institutions are paid even if they fail to enroll a single subject. ATCG funding for direct costs is being
linked to performance.
ACT UP DEMANDS
The ACTG must conduct small, quick clinical studies of new drugs, rather than large, long-term studies of
existing drugs such as AZT.
THE FACTS
Both small, Phase I studies that primarily measure drug safety and dosage and large efficacy trials are
important. Since its inception, the ACTG has conducted Phase I trials and will continue to do so as
promising new agents emerge from preclinical research. Phase I studies of ddl, ddC and soluble CD4 were
completed and these agents are now being further studied within the ACTG. Phase I studies of soluble CD4 -IgG and N-butyl DNJ are under way. In addition, studies of ribavirin, dextran sulfate, ampligen, and AL721 yielded negative results and, therefore, these drugs are not being pursued.

ACTG clinical trials now in progress include 36 Phase I or Phase I/II studies.