NEURO-AIDS:  HIV-I INFECTION AND THE NERVOUS SYSTEM

NIH GUIDE, Volume 21, Number 27, July 31, 1992



PA NUMBER:  PA-92-95



P.T. 34



Keywords:

  AIDS 

  Nervous System 

  Neuroscience 



National Institute of Neurological Disorders and Stroke

National Institute of Mental Health



PURPOSE



The National Institute of Neurological Disorders and Stroke (NINDS) and

the National Institute of Mental Health (NIMH), components of the

National Institutes of Health (NIH), invite research grant applications

through this Program Announcement (PA) for support of research on

neurological aspects of human immunodeficiency virus (HIV) infection

(neuro-AIDS) in adults and children.  It is well recognized that HIV-I

infection, directly and/or indirectly, causes central and peripheral

nervous system abnormalities that later may be compounded by

opportunistic infections and malignancies.  Applications are solicited

covering a broad range of activities in the neurological sciences from

basic research to diagnosis and management of neurological

complications including therapeutic investigations of HIV-related

neurological disease in adults and children.  Research applications

supporting the establishment or enlargement of collaborative and

consultative neurologic units coordinated with AIDS Clinical Treatment

Units (ACTUs) of the AIDS Clinical Treatment Group (ACTG), Women and

Infants Transmission Study (WITS), and Multicenter AIDS Cohort Study

(MACS) supported by the National Institute of Allergy and Infectious

Diseases (NIAID) are especially solicited but are not required.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This PA,

Neuro-AIDS:  HIV-I Infection and the Nervous System, is related to the

priority area of HIV infection.  Potential applicants may obtain a copy

of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic institutions,

for-profit and non-profit organizations, public or private, such as

universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal Government.

Foreign institutions are only eligible to apply for research project

grants (R01).  Applications from minority institutions, minority

individuals, and women are particularly encouraged.



MECHANISMS OF SUPPORT



Research support may be requested through application for an individual

investigator originated Research Project Grant (R01).  Applications

from new investigators who have not received previous PHS research

grant support may apply for a First Independent Research Support and

Transition (FIRST) Award (R29).   To apply for the support of a more

broadly based multidisciplinary research program, the Research Program

Project (P01) mechanism is suggested.



RESEARCH OBJECTIVES



Neurological abnormalities and associated psychomotor and

neurodevelopmental problems may be the first presenting symptoms of

AIDS.  Many advanced AIDS patients exhibit neurological dysfunction,

and as many as 90 percent of the cases may demonstrate

neuropathological changes at autopsy.  It appears that the AIDS virus

enters and affects the nervous system by way of macrophage infection

and release of neurotoxic cytokines.



In primary neuro-AIDS, involvement of every level of the central and

peripheral nervous system (PNS) has been reported:  dementia,

meningitis, encephalitis, encephalopathy, myelopathy, peripheral

neuropathy, and polymyositis.  Myopathies, neuropathies, and other

neurological side effects of current treatment are also known.

Management and treatment of neurological complications of opportunistic

infection and HIV related malignancies remains a significant challenge.



This PA is an NINDS and NIMH call for increasing the effort on research

studies of neuro-AIDS in adults and children. Increasing recognition of

neurological aspects and complications of AIDS indicates that

recruitment and greater involvement of neuroscientists in this disease

is desirable.  This PA is intended to motivate individual scientists,

inter-disciplinary research teams, and collaborative alliances to apply

for research support to establish financially autonomous, but

scientifically integrated, neuro-AIDS research nuclei particularly in

partnership with ACTUs, MACS, and WITS.



Examples of research objectives appropriate for an application in

response to this PA include:



o  Studies of HIV-I infection of the CNS and subsequent neuro-AIDS

complications in adults and children;



o  Studies of AIDS-associated disorders of the PNS and resulting

dysfunctions and abnormalities;



o  Studies of the neurological complications of AIDS and its treatment

and of opportunistic infections and malignancies;



o  Studies of prevention, control, and treatment of opportunistic

infections of the nervous system, such as progressive multifocal

leukoencephalopathy cytomegalovirus toxoplasmosis, and fungal

infections;



o  Neuro-imaging studies of the manifestations of neuro-AIDS including

positron emission tomography magnetic resonance imaging, magnetic

resonance spectroscopy;



o  Epidemiological studies of neuro-AIDS.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements will be required to include minorities and women

in study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder or condition under study;

special emphasis should be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to apply

to males and females of all ages.  If women or minorities are excluded

or inadequately represented in clinical research, particularly in

proposed population-based studies, a clear compelling rationale should

be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.  Applicants are urged to assess carefully the feasibility of

including the broadest possible representation of minority groups.

However, NIH recognizes that it may not be feasible or appropriate in

all research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaska Natives), Asian/Pacific

Islanders, Blacks, Hispanics).  The rationale for studies on single

minority population groups should be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned to the applicant without review.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted for an accelerated review cycle on any

of the three AIDS application receipt dates:  September 1, January 2,

and May 1.  Only applications submitted for the September and January

deadlines would qualify for Fiscal Year 1993 funds.  The NINDS

Application Guidelines (rev. 4/92) for Program Project (P01) Grants are

available upon request from the Program Administrator identified below

(see INQUIRIES).



Application kits are available at most business and grants and

contracts offices and may be obtained from the Office of Grants

Inquiries, Division of Research Grants, National Institutes of Health,

Westwood Building, Room 449, Bethesda, MD  20892, telephone (301)

496-7441.



On the first (face) page, item 2a of the application, the word "yes"

must be checked and the title and number of the announcement typed in

the space provided:  "Neuro-AIDS: HIV-I Infection and the Nervous

System, PA-92-95."



The original and five copies of the application must be sent or

delivered to:



Application Receipt Office

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD   20892**



The Division of Research Grants, NIH, serves as a central point for

receipt of applications.



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources,

and/or ACTUs, MACS, and WITS funded by the NIAID may wish to identify

the GCRC and/or ACTUs, MACS, and WITS as a resource for conducting the

proposed research.  In such a case, a letter of collaboration from the

GCRC, ATCU, MACS, and WITS Program Director or Principal Investigator

must be included with the application.



REVIEW CONSIDERATIONS



Applications received under this PA will be assigned to the Initial

Review Group (IRG) in accordance with established PHS referral

guidelines.  The IRGs, which are composed primarily of non-Federal

scientific and technical experts, will review the applications for

scientific and technical merit.  Following IRG review, the applications

will receive a second-level review by one or more appropriate advisory

councils.



AWARD CRITERIA



The standard review criteria will be used to assess the scientific

merit of applications.



Applications will compete for available funds with all other

applications.  The following will be considered when making funding

decisions:



o  Quality of the proposed projects as determined by peer review;

o  Availability of funds;

o  Program balance among research areas.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Dr. A. P. Kerza-Kwiatecki

Program Administrator

Division of Demyelinating, Atrophic, and Dementing Disorders

National Institute of Neurological Disorders and Stroke

Federal Building, Room 804

Bethesda, MD  20892

Telephone:  (301) 496-1431

FAX:  (301) 402-2060



or



Dr. Walter L. Goldschmidts

Office of AIDS Programs

National Institute of Mental Health

Parklawn Building, Room 15-99

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-7281

FAX:  (301) 443-9719



Direct inquiries regarding fiscal matters to:



Ms. Laura Williams

Grants Management Specialist

Grants Management Branch, Division of Extramural Activities

National Institute of Neurological Disorders and Stroke

Federal Building, Room 1004

7550 Wisconsin Avenue

Bethesda, MD  20892

Telephone:  (301) 496-9231

FAX:  (301) 402-0219



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.853 and 93.242.  Awards are made under authorization of the

Public Health Service Act, Title IV, Part A (Public Law 78-410, as

amended by Public Law 99-158, 42 USC 241 and 285) and administered

under PHS grants policies and Federal Regulations  42 CFR 52 and 45 CFR

Part 74.  This program is not subject to the intergovernmental review

requirements of Executive Order 12372 or Health Systems Agency review.



.

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