ACTG Highlights

3

ACT UP ALLEGES
The ACTG has failed to provide children with AIDS with any treatments whatsoever.
THE FACTS
Untrue. ACTG Phase I and II trials of AZT in children formed the basis for the recent approval of AZT for
children 3 months and older. In addition, ACTG studies determined the safety of AZT for children from I
day to 3 months old. Enrollment has been completed for a Phase I ddl trial in children and another Phase I
trial of soluble CD4 in children has been initiated.
Eight pediatric clinical trials are scheduled to begin in 1990, including Phase II studies of ddC and ddl, an
evaluation of oral AZT in infants with perinatal exposure and a study of the use of AZT to block
transmission from HIV-infected pregnant women to fetuses; Phase I studies of CD4-IgG in pregnant women
and infants, and a dose deposition study of aerosolized pentamidine are also planned.
ACT UP ALLEGES
ACTG trials routinely exclude present and former drug users, people of color, and women.
THE FACTS
Untrue. Exclusion criteria in ACTG studies exist for medical indications only.
ACT UP ALLEGES
The ACTG has researched only one immune-enhancing drug, interleukin-2 (M-2), and has used the failure of
this drug to block research on other immune boosters.
THE FACTS
Untrue. The ACTG has studied, or will study in 1990, many immune modulators, including interferon alpha,
interferon beta, interferon gamma, granulocyte macrophage colony-stimulating factor (GM-CSF), tumor
necrosis factor, ampligen, intravenous gamma globulin, AS-101, HIV immunoglobulin (HIVIG), recombinant
HIV gpl60 antigen, and IL-2 augmented CD8 cells.
ACT UP ALLEGES
The ACTG has not allowed people with AIDS and their advocates to participate in selecting research
priorities and designing clinical trials.
THE FACTS
MAID values the perspective of patients and their advocates. They serve on many Institute advisory and
review groups, including the NIAID Advisory Council, the AIDS Research Advisory Committee, and the
AIDS Clinical Drug Development Committee. These groups advise MAID on a broad range of scientific
activities and research priorities. The ACTG has established a Patient Constituency Working Group, including
22 individuals representing those constituencies most affected by the HIV epidemic, which is drawing up
specific recommendations for constituent involvement in the ACTG process.
ACT UP ALLEGES
Less than 1 percent of the American population with AIDS have had the opportunity to participate in ACTG
clinical trials.
THE FACTS
The purpose of clinical trials is to identify effective therapies, not to provide treatment for large numbers of
people. Studies involving no more than a few hundred patients can yield results that benefit many thousands;