ACTG Highlights

Preclinical Of

smooth and rapid transition of promising agents from the laboratory through preclinical
development to human clinical trials.
DTB, headed by Margaret Johnston, Ph.D., is a national resource for any individual
or group of scientists interested in developing drugs against HIV and its associated Ols.
DTB staff members assist scientists in obtaining necessary resources, facilitate their efforts
to meet Food and Drug Administration guidelines for Investigational New Drug
applications, and offer guidance on the potential clinical utility of novel agents. DTB also
works closely with the DAIDS Treatment Research Program to assure that the best drugs
reach the clinic quickly.
In addition, DTB coordinates a structured program on Ols comprising the following
five efforts:
1. The National Cooperative Drug Discovery Groups for Opportunistic Infections
(NCDDG-OI) program.
2. Investigator-initiated basic research grants.
3. Contracts to identify agents active against opportunistic pathogens.
4. Contracts to analyze the efficacy and toxicity of single and combination
therapies in animal models.
5. Resources to conduct chemical formulation and synthesis studies.
National Cooperative Drug Discovery Groups for Opportunistic Infections
NIAID has set aside $3 million in Fiscal Year 1990 to fund first-year research for
several new NCDDGs established specifically to develop treatments for HIV-related Ols.
Twenty-four applications for research on major opportunistic pathogens such as
Pneumocystis carinii, Cryptosporidium, Toxoplasma gondii, Candida, Cryptococcus
neoformans, Mycobacterium avium, and cytomegalovirus were received by the December 8,
1989, deadline; awards are expected to be made in June. Each group will be funded for
between 3 and 5 years.
The NCDDG-OI initiative, under the direction of H. S. Allaudeen, Ph.D., is modeled
on the NCDDG-AIDS program. This latter program, now comprising 28 groups, has been
extremely successful in fostering teams of industry, academia, and government scientists to
develop new anti-HIV drugs.
The Request for Applications (RFA) for the existing NCDDG-AIDS program did not
preclude research on Ols, but no 01 applications were ever received. Therefore, it was
decided that a separate RFA under the NCDDG mechanism should be issued to attract 01
proposals.
DAIDS believes that a separate drug discovery program for Ols will stimulate the
field and help find better ways to treat these diseases. Treatment of Ols is vitally
important since it is one of the key areas where treatment may actually help prolong
patients' lives.

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