AIDS Research at the NIH: A Critical Review

previously underrepresented in clinical research. The CPCRA cannot decide whether it wants to be a miniACTG or whether it wants to conduct a different kind of research (for example, low-tech trials which
optimize the standard of care). So far, most participants have enrolled in the ODB, with 433 enrolled in
a toxoplasmosis prophylaxis study (now closed), 467 in a ddl vs. ddC comparison, and an unknown number
in a MTB prophylaxis study. A study of fluconazole for vaginal candidiasis is in development. Of the
CPCRA's 5,022 participants, 20% (978) are women, 15.6% (703) Latino/Hispanic, 40.8% (1,987) AfricanAmerican, 42.3% (2,139) white, 0.4% (21) Asian/Pacific Islander, 0.2% (13) Aleutian Eskimo/Native
American, and 0.7% (41) Other/Unknown. Underrepresented populations represent more than half of the
CPCRA participants, but, needless to say, since 95% of them are on the Observational Database, and only
<5% on a treatment trial, most of them are not being treated in Federally-sponsored protocols. This
explains HHS Secretary Louis W. Sullivan's argument that 'minorities now represent more than 50% of
those participating in all PHS-sponsored HIV-related clinical trials."
Division of AIDS Treatment Research Initiative (DATRI). DATRI is a new, extramural, contract-funded
mechanism by which NIAID can conduct fast, early phase studies and trials of compounds which are not
high priorities within the ACTG or the CPCRA, but which should be studied for public health or other
reasons. The DATRI was formed by NIAID after years of activist criticism that the ACTG was incapable
(and sometimes unwilling) to conduct efficient phase one trials of novel agents or approaches. NIAID
floated an RFA in 1991 for DATRI, and developed a new network of 40-50 sites willing to conduct studies
under contract. DATRI cost $4.3M in FY 1991 and will cost $5.9M in FY 1992. DATRI's first four studies
are: pharmacokinetic interactions of rifabutin with clarithromycin or azithromycin; 12 weeks of AZT or
placebo in people with acute primary HIV (before seroconversion); a study of lymph node viral burden preand post-treatment with nucleosides; and megace, dronabinol or both for the wasting syndrome.
Fundina + Future Plans. NIAID's AIDS budget was $431M in 1991, $450M in 1992 and will be $471M
under the President's 1993 budget. In 1991 AIDS accounted for amounted to 47.7% of NIAID's total
budget and $53.4% of the NIH AIDS budget. NIAID requested $594M in FY 1993 - an increase of $144M -
but received only $21 M in new funds (4.7%), barely enough to keep up with inflation. The President cut
$124M from NIAID's request. NIAID had to cut the award rate (percentage of approved applications which
are funded) in half this year, from 40% in FY 1991 to 19% in 1992. The number of AIDS grants awarded
this year will also suffer, dropping from 156 last year to just 123 this time. There are 281 full-time
equivalent (FTE) AIDS employees at NIAID in FY 1991, of whom 119 were at DAIDS. AIDS FTEs will rise
to 355 at NIAID and 133 at DAIDS in FY 1992-93. While in 1991, 40% of the appxroved AIDS grants were
funded, that rate will drop to 19.9% in 1992. According to a NIAID staffer, "the drop in the estimated FY
1992 award rate is because of the substantial amount of resources required for the adult ACTU
recompetition and the dollars needed to fund the Pediatric AIDS clinical trial earmark. These in
combination will result in fewer competing grants being funded." This year, at least, basic research is being
starved to pay for the renewed ACTG. The items which NIAID wished to fund in FY 1993 were:
Basic research
* $12.6 million for new extramural virology projects (R01s);
* $12.6M for new extramural immunology projects (ROls);
* $9M for intramural work on pathogenesis and drug development;
* $2.3M to study mucosal immunity;
* $165,000 for animal models of Ols;
* $2.6M to expand the CFARs;
* $118,000 to study CD4-induced changes in gpI60/gpl20;
* $2M to develop rapid methods to detect antigenic variation among HIV isolates worldwide;
* $90,000 for intramural development of NF-kB dominant negative mutants;
* $500,000 to renew the 1988 AIDS Research & Reference Reagents Program;

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