A Critique of the AIDS Clinical Trials Group

Introduction:
WHERE THE AIDS CLINICAL TRIALS GROUP IS AT DECADE'S END
by Jim Eigo
L
The ACTG (AIDS Clinical Trials Group) is the most generously-endowed clinical trials system ever. The
ACTG and its predecessor ATEU (AIDS Treatment Evaluation Unit) have been in existence about 3-and-a-half
years.
The one FDA-approved drug for AIDS, AZT, highly toxic and marginally effective for a limited period of time,
was developed outside the ACTG. The ACTG has yet to yield a new anti-AIDS drug.
The majority of AIDS-related opportunistic infections (Ols) have no relatively safe, FDA-approved treatments.
The ACTG has yet to yield a new drug to treat an AIDS related opportunistic infection.3
Of AIDS-related Ols, only Dneumocystis carinii pneumonia (PCP) has any approved "prophylaxis'. The
ACTG has yet to yield a new drug to prophylax against any 01.
Because their immune systems are partially destroyed, people with AIDS will need therapies that, in addition
to fighting the virus, rebuild the immune system. The ACTG has yet to yield a drug to boost the immune
system.
None of the ACTG's current high priority trials tests a drug that attacks AIDS in a way significantly different
from AZT. None of the ACTG's current high priority trials tests a drug for new treatment or prophylaxis
against an AIDS-related 01. None of the ACTG's current high priority trials tests a drug to boost the immune
system.
Results from the few high priority trials that have been completed (on the dosage and uses of AZT) leave
us with many questions about treatments in the real world. (For example: what is the minimal effective
dose of AZT? Do you treat people who are asymptomatic with AZT if they've stabilized with 450 T-cells?).
All of the long-term, large efficacy trials have either already closed and yielded all the data they likely ever
will, or failed.
All of the newly-opened high-priority trials are for drugs similar to AZT and are recruiting trial participants
nearly as slowly as previous trials.
Because of an upcoming Shift in the ACTG's system of data management, no new large efficacy trials will
oDen in the next 9 months.
In the foreseeable future, we cannot hope for results from any major ACTG trials, whether they be ongoing,
new or prospective.
Leaders of the ACTG have been unable to convince local investigators of the necessity of a "Parallel Track."
Since this was written, FDA has approved Fluconazote for AIDS-associated fungal infections; it is
unclear whether data fromrACTG 026 and 059 contributed to this.
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