ACTG Highlights

Does the ACTG Use Standard-of-Care Prophylaxis?

Prophylaxis that has been demonstrated to be effective in reliable studies is permitted in ACTG
studies. At this time, the only 01 for which this is the case is PCP. Prophylaxis for other Ols
has not been demonstrated to be effective, although NIAID recognizes that in some selected
communities some agents may be used frequently. NIAID does not believe it is in the patient's
best interests to encourage the use of multiple prophylactic regimens, the toxicities of which are
likely to adversely affect quality of life, unless there is evidence that such regimens are
effective.
What is the Purpose of the ACTG's Strict Eligibility Criteria for its Studies and the
Restrictions on Participants' Taking Other Medications Concomitantly?
Certain patients must be excluded from studies on the basis of their health status, or because
they are taking medications that may interfere with the action of the treatment under study.
Exclusion criteria for clinical trials exist for medical purposes only. These exclusions ensure
that the results are as clear and unequivocal as possible, and can be used by physicians when
making decisions about treating their patients.
Realizing that some research questions may lend themselves to less strict protocol requirements,
the ACTG has recently designed some protocols with less strict eligibility criteria and fewer
restrictions on concomitant medications.
It is important to note that clinical trials are designed to identify effective and safe therapies,
not to provide treatment for large numbers of people. Studies involving only a few hundred
patients can, and often do, yield results that benefit many thousands.
What is the Relationship Between the ACTG and the AIDS Clinical Drug Development
Committee (ACDDC)?
The ACDDC was established in December 1986 to advise the MAID on the scientific merit and
relative importance of agents proposed for clinical trials. It is completely independent of the
ACTG, although its membership includes some ACTG investigators, as well as some
Community Programs for Clinical Research on AIDS (CPCRA) investigators. The independent
advice and recommendations of the ACDDC are important factors in the decision on whether an
agent will enter clinical development under MAID sponsorship. The actual development plan
and specific studies are formulated by ACTG or CPCRA investigators and NIAID staff.
How Does NIAID Ensure that ACTG Investigators' Decisions On What Drugs to Stud
Are Made Objectivell?
Collaboration between government, academia, and industry has contributed significantly to the
success of applied biomedical research in the United States. Given this collaboration, and the
prevailing reality of consulting arrangements between researchers and industry, the National
Institutes of Health is addressing concerns about the potential appearance of conflict of interest.
MIAID and the ACTG will, of course, work within the NIH policies that are developed.
In any case, individual investigators do not have the authority to direct or dictate ACTG
research priorities. The ACTG Executive Committee, which guides the ACTG, is composed of
one MIAID representative, one SDAC representative, and 8 ACTG investigators. Three of the

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