ACTG Highlights

NIAID RESPONDS TO ACT UP ALLEGATIONS AND DEMANDS

The AIDS Clinical Trials Group (ACTG) of the National Institute of Allergy and Infectious
Diseases (NIAID) was established to evaluate promising therapies for use against the human
immunodeficiency virus (HIV), the cause of AIDS, and the opportunistic infections (Ols) and
cancers that characterize AIDS. The ACTG's goals are to conduct studies that will (1) provide
timely information to guide physicians in the selection of appropriate therapies for their patients
and (2) lead to the approval of new drugs.
The AIDS Coalition to Unleash Power (ACT UP) has distributed documents containing a
number of inaccurate statements, allegations and demands concerning the activities of the ACTG
to which the NIAID has made the following responses.
ACT UP ALLEGES
The ACTG has produced no new drugs for people with human immunodeficiency virus (HIV) infection.
THE FACTS
Clinical trials of virtually all antiretroviral drugs with significant promise have been or will be conducted by
the ACTG. The fact is that, except for AZT and a few related compounds, very few promising antiretroviral
drugs have yet emerged from preclinical research; thus few are available for testing. The antiretroviral drugs
ddl and ddC are now in ACTG efficacy studies; other antiretroviral drugs are in earlier phases of ACTG
research, to provide information on toxicity, appropriate dose, and indications of possible efficacy.
ACT UP ALLEGES
The ACTG has added only incremental knowledge about existing treatments such as AZT.
THE FACTS
On the contrary, because of clear evidence gained through ACTG clinical trials, 400,000 Americans with early
or asymptomatic HIV disease can now receive AZT and thus slow the progression of their disease. ACTG
studies proved AZT's effectiveness in delaying the development of HIV symptoms in persons with
asymptomatic and early HIV disease. In addition, the ACTG demonstrated the effectiveness of AZT for
patients at all stages of disease at a dose level half that specified at the time of the drug's approval. This
research has already had a dramatic impact on the lives of persons infected with HIV.
ACT UP ALLEGES
Even when the ACTG has found information useful to people with AIDS, months have passed before these
findings (AZT for early intervention, lower dose AZT) were translated into clinical practice.
THE FACTS
This is inaccurate. When clinical trials have been halted early by a Data and Safety Monitoring Board
(DSMB), MAID has promptly disseminated information widely to physicians and other health care
professionals, constituency groups, and the scientific and medical press.
Within 2 weeks of the halt of the ACTG clinical trial of AZT in asymptomatic HIV-infected persons (ACTG
019), MIAID issued a Note to Physicians to thousands of doctors and professional medical organizations. The
note summarized the results of 019, including the finding that AZT at lower doses was equally effective and
less toxic than the drug given at higher doses. In addition, a clinical trials alert described the results of 019