Release Date:  January 28, 2000

PA NUMBER:  PA-00-048

National Institute of Allergy and Infectious Diseases
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Mental Health

Receipt Date:  May 8, 2000


The National Institute of Allergy and Infectious Diseases (NIAID), the 
National Institute on Drug Abuse (NIDA), the National Institute on Alcohol 
Abuse and Alcoholism (NIAAA), National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK) and National Institute of Mental Health (NIMH) invite 
applicants to expand the clinical knowledge of the complications of HIV by 
expediting the translation of promising innovative preclinical findings into 
clinical research applications. NIAID, NIDA, NIAAA, NIDDK and NIMH are 
interested in supporting focused collaborative research between preclinical 
and clinical scientists to test, refine, and improve diagnostic, pathogenic, 
or therapeutic concepts.  It anticipates such research will lead to innovative 
approaches for the prevention and management of complications causing 
significant morbidity or mortality in HIV infected persons, including the 
recently recognized metabolic complications, coincident pathogens such as 
hepatitis C virus, and the opportunistic pathogens.  This type of 
collaborative research would be dedicated to the expedited development and use 
of advanced preclinical findings into clinical applications and would be 
designed to: elucidate pathogenic mechanisms involved in metabolic 
dysregulation or in the human host-pathogen relationship in HIV-associated 
complications; develop strategies to prevent or treat complications of HIV or 
HIV therapy; or develop approaches to measure treatment response. The NIDA 
will support research on metabolic disorders in drug users with HIV infection.  
The NIAAA is interested in supporting research as it relates to alcohol 
consumption as a cofactor in HIV infection.  The NIMH will support research on 
the neurobiological/neuropsychiatric complications of HIV infection and 
associated therapies. 

The program encourages investigators to engage in interdisciplinary and 
collaborative research that focuses on clinical as well as basic studies and 
fosters collaborations among scientists with different expertise, abilities, 
and talents.  Among the disciplines and expertise that may be appropriate for 
this research program are clinical investigation, immunology, microbiology, 
virology, endocrinology, pharmacology, molecular and cell biology, genetics, 
biostatistics, neuropathology/neuropsychiatry, and diagnostic radiology.  The 
collaborations should focus on a common hypothesis with all component projects 
contributing scientifically to the central theme.  The collaborative projects 
may include shared resources as long as the interdependence and multi 
disciplinary nature of the individual components is demonstrated.  
Applications that include collaborations with the private sector (e.g., 
pharmaceutical, chemical, or biotechnological companies) are strongly 

Research projects that propose the development of new and advanced 
technologies for the development of targeted therapies, diagnostic tests, or 
tests for the monitoring of clinical response may also be within the areas of 
programmatic emphasis described in PAR-98-073,  "Small Business Innovation 
Research Advanced Technology: NIAID (SBIR-AT-NIAID)" published in the NIH 
Guide May 22, 1998 and updated on August 16, 1999 or PAS-00-006, 
"Bioengineering Research Partnerships" Published in NIH Guide October 15, 

Research projects that principally encompass preclinical laboratory research 
are not within the area of interest of this PA, but may be within the areas of 
programmatic emphasis described in PA-99-124,"Innovative Drug Discovery 
Research in AIDS Opportunistic Infections," published in the NIH Guide, July 
9, 1999.  


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS led national 
activity for setting priority areas. This Program Announcement (PA), 
“Collaborations for Advanced Strategies in Complications of HIV Infection”, is 
related to one or more of the priority areas including HIV Infection and 
Substance Abuse.  Potential applicants may obtain a copy of "Healthy People 
2010" at


Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government. Racial/ethnic minority individuals, women, 
and persons with disabilities are encouraged to apply as principal 

Applicants must propose a multi disciplinary program, comprising basic and 
clinical science studies to be performed at one or more institutions.  
Investigators are encouraged to establish appropriate collaborations to meet 
the objectives of this PA.  Collaborative groups may consist of either two or 
three research projects consisting of basic science and clinical studies, with 
a common theme.  Interactions between basic and clinical scientists are 
expected to strengthen the research, enhance the transfer of fundamental 
research findings to the clinical setting, and identify new research 
directions.  A coordinated multidisciplinary effort exploring focused 
questions can facilitate rapid advancements and lead to innovative approaches 
for identification and optimal treatment of high risk individuals.  Such 
approaches may have a more than average risk-to-benefit ratio, but are likely 
to have greater potential for effective, long-term therapeutic returns.  Plans 
for the transfer of findings from basic to clinical studies should be 
described.  Applications not proposing both basic and clinical research 
studies will not be considered responsive to this solicitation. 


This PA will use the National Institutes of Health (NIH) research project 
grant (R01) award mechanism. Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant. The 
total project period for an application submitted in response to this PA may 
not exceed 5 years.

This PA has one annual receipt date. Future unsolicited competing continuation 
or revised applications will compete with all investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is December 2000.

The funding decision will be influenced by the scientific merit of the 
individual applications, the degree of collaboration among the investigators, 
the approaches taken to meet the objectives of the PA, and the programmatic 
balance and needs of National Institute of Allergy and Infectious Diseases 
(NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), 
National Institute of Drug Abuse (NIDA) and National Institute of Mental 
Health (NIMH).  Although applicants are required to submit collaborative 
applications, the NIAID, NIDDK, NIDA or NIMH may choose to fund individual 
R01s outside the collaborative arrangement owing to their special scientific 
merit and programmatic needs and balance.



The introduction of potent antiretroviral regimens has resulted in marked 
reductions in the incidence of opportunistic infections and dramatic declines 
in mortality for persons with HIV in the United States  [Surveillance for 
AIDS-Defining Opportunistic Illnesses, 1992-1997.  MMWR. April 16, 1999/ 
48(SS-2); 1-22].

The beneficial effects of potent antiretroviral regimens are tempered by newly 
recognized metabolic complications.  Patients treated with anti-retrovirals 
are presenting with a myriad of metabolic complications representing 
alterations in lipid and glucose metabolism.  Clinicians are noting increasing 
cases of hyperlipemia, hyperglycemia, hyperinsulinemia and altered body 
habitus. The most commonly reported body habitus changes are loss of fat of 
the face and extremities, increase in abdominal fat, dorsocervical fat 
deposition and lipomas.  Many of these metabolic complications are well known 
risk factors for cardiovascular disease in the general population.  There have 
been reported cases of heart attack and angina among patients receiving highly 
active antiviral therapy treatment suggesting that premature atherosclerosis 
may be occurring.  Clinical studies have been designed to estimate the 
prevalence and incidence of the complications, risk factors and to define the 
syndromes.  The pathogenesis and long-term consequences of these complications 
are unknown.  In addition, the neuropathological/neuropsychiatric 
complications associated with anti-retroviral therapy have not been 
extensively studied.  The significant dysregulation of glucose and lipid 
metabolism that accompany HAART therapy could contribute to CNS vascular 
disease that results in serious neurologic functional deficits. 

Expectations of longer survival of HIV-infected persons raise concerns about 
the long-term sequelae of other chronic infections, such as hepatitis C virus 
(HCV).  The natural history of HCV infection in persons co-infected with HIV 
is poorly understood, as are the mechanisms of pathogenesis and protective 
immunity. Ideal methods for detecting HCV infection, assessing HCV disease 
status and monitoring disease progression are not available.  Of particular 
concern are the interactions between HIV and HCV, including the impact of HIV 
on HCV disease progression and the impact of HCV on HIV disease progression.  
HCV-induced liver disease, the complications of HIV and its therapies, and the 
overlapping toxicities of available HCV and HIV therapies impair the abilities 
to provide the best available treatments for HIV and HCV infections. 

While increasing attention needs to be focused on these newly recognized 
health threats, efforts must be maintained to enhance the prevention and 
management of the traditional opportunistic infections in persons with AIDS.  
Critical areas of research include better knowledge of the HIV-associated 
immune defects that render infected persons unable to prevent or overcome 
diseases caused by these organisms; the extent and duration of immune function 
restoration by highly effective antiretroviral regimens; immunomodulatory 
strategies to prevent and or treat infection; and the development of new OI 
therapies that can overcome drug resistance.

Proposed Research

Appropriate topics for investigation may include, but are not limited to, the 


Elucidation of mechanisms and molecular sites of lipid and glucose 

Determination of the significance of histological and biochemical changes in 
fat cells in body regions affected by abnormal fat distribution

Development and testing of new methods for quantifying regional fat

Determination of the extent and the significance of cellular metabolic changes 
caused by HIV-infection or specific antiretroviral therapy

Determination of the interactions of alcohol-induced metabolic complications 
and the metabolic complications of HIV disease and its treatment including 
triglyceridemia, lipodystrophy, glucose dysregulation and cardiovascular 

Determination among drug users with HIV infection the clinical manifestations 
and underlying mechanisms of metabolic complications or the interactions 
between drugs of abuse and therapeutic agents used in the treatment of 
metabolic disorders. 

Evaluation of therapeutic strategies and preliminary clinical testing, with 
modifications as necessary based on clinical research findings

Study of vascular complications in the CNS as a result of HAART therapy that 
contribute to neurologic and neuropsychiatric deficits


Elucidation of viral and host factors contributing to HCV pathogenesis and 
disease progression in HIV-infected persons

Elucidation of the contribution of alcohol and drug use to HCV pathogenesis 
and disease progression in HIV-infected persons

Development of methods for improved detection of HCV infection and monitoring 
of disease progression and response to treatment in HIV-infected persons

Evaluation of innovative therapeutic strategies for treatment of HCV in HIV-
infected persons


Elucidation of immune responses to the infection occurring in HIV-infected 
individuals, and identification of features of immune dysregulation
Clinical evaluation of methods for early detection of infection and 
quantitative assessment of response to therapy in inaccessible infections 
(e.g., quantitative PCR, surrogate markers)
Evaluation of innovative therapeutic strategies (e.g., immune-based therapies, 
gene-based approaches, novel antimicrobials) and preliminary clinical testing, 
with modifications as necessary based on clinical research findings

Determination of the role of chronic alcohol abuse -induced immune modulation 
(induction of Th2 cytokine responses) in progression of opportunistic 
infections, particularly tuberculosis

Study of chronic opportunistic infections in the brain that impact on neuronal 


Terms and Conditions of Award

The NIH has responsibility to ensure the safety of participants in studies 
that it supports. Terms and conditions addressing NIH review of clinical 
protocols, reporting requirements, time-sensitive notifications to the Food 
and Drug Administration, and requirements for Data, Safety, and Monitoring 
Boards may be incorporated into the Notice of Grant Award and provided to the 
Principal Investigator as well as the institutional official at the time of 
award.  These terms and conditions are a reiteration of and in addition to, 
and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 
grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is 
applicable when State and local Governments are eligible to apply], and other 
HHS, PHS, and NIH grant administration policies.

B.  Federally Mandated Regulatory Requirements
The research project must be in compliance with all Federal regulations and 
NIH policies that apply to the conduct of research involving human subjects.  
These include, but are not limited to, Title 21 CFR 50, 56, 312, and Title 45 
CFR 46.  The research project must be able to demonstrate that: (1) each 
institution conducting clinical trials has a current, approved Assurance 
Number on file with the NIH Office for Protection from Research Risks (OPRR); 
(2) each protocol and informed consent is approved by the responsible 
Institutional Review Board (IRB) prior to subject entry; (3) each investigator 
has supplied a completed (including curriculum vitae) FDA 1572 to the Division 
of AIDS for each protocol conducted at each site; and (4) each subject (or 
legal representative) gives written informed consent prior to entry on study.  
C.  Patent Coverage
Because the development and availability of innovative, effective strategies 
for the clinical management of complications of HIV is the principal goal of 
this PA, and because active involvement by the private sector is facilitated 
by the existence of adequate patent coverage, it is essential that applicants 
provide plans to ensure such coverage.  

Since several institutions may be involved in this collaborative research, 
complex patent situations may arise.  Each applicant must therefore provide a 
detailed description of (1) the approach to be used for obtaining patent 
coverage and for licensing where appropriate, in particular where the 
invention may involve investigators from more than one institution; and (2) 
the procedures to be followed for the resolution of legal problems that 
potentially may develop.  Attention is drawn to the reporting requirements of 
35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions 
were also published in the NIH Guide for Grants and Contracts, Vol. 19, No. 
23, June 22, 1990.  Note that non-profit organizations (including 
universities) and small business firms retain the rights to any patent 
resulting from Government contracts, grants or Cooperative Agreements.
It is also noted that a Presidential memorandum of February 18, 1983 extended 
to all business concerns, regardless of size, the first option to the 
ownership of rights to inventions as provided in P.L. 96-517.  As a result of 
this memorandum, the relationships among industrial organizations and other 
participants are simplified, since all members can now be full partners in the 
research and in any inventions resulting therefrom.  The specific patenting 
arrangements among the institutions may vary, and could include joint patent 
ownership, exclusive licensing arrangements, etc.  Applicants are encouraged 
to develop an arrangement that is most suitable for their own particular 
The patent agreement among the collaborating institutions, signed and dated by 
the organizational officials authorized to enter into patent arrangements for 
each investigator and institution, must be delivered to Dr. Barbara Laughon 
prior to an award at the address listed under INQUIRIES.  A copy of the 
proposed patent agreement may be submitted with the application with Appendix 
materials.  If the collaborators wish to place all inventions and discoveries 
resulting from these studies within the public domain, a letter to that effect 
must be submitted to Dr. Laughon in lieu of the patent agreement prior to 
award.  The letter must be co-signed by the Principal Investigator, each 
investigator, and each of the business officials representing the respective 

Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR 
Parts 6 and 8 require that NIH be informed of inventions and licensing 
occurring under NIH funded research.  Invention and licensing reports must be 
submitted to the Division of Extramural Invention and Technology Resources, 
Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 3188, Bethesda, 
MD 20892.

It is the policy of NIH that women and members of minority groups and their 
subpopulations must be included in all NIH supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification is provided that inclusion is inappropriate with 
respect to the health of the subjects or the purpose of the research. This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public 
Law 103-43).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994 available on the web at the following URL address:


It is the policy of NIH that children must be included in all human subjects 
research, conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial (Type 
1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998.  This document is available at the 
following URL address:

For purposes of this PA, children are classified as individuals under the age 
of 18.  Investigators may obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff also may provide additional 
relevant information concerning the policy.


Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the stated deadline.  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone 301/710-0267, email:, or at the 
following URL address:

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed. Furthermore, the application 
must obtain agreement from the IC staff that the IC will accept the 
application for consideration for award. Finally, the applicant must identify, 
in a cover letter sent with the application, the staff member and Institute or 
Center who agreed to accept assignment of the application.  This policy 
requires an applicant to obtain agreement for acceptance of both any such 
application and any such subsequent amendment. Refer to the NIH Guide for 
Grants and Contracts, March 20, 1998 at

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC program director or Principal 
Investigator could be included with the application.  Applicants from an 
institution receiving government funds under Center for AIDS Research (CFAR), 
AIDS Clinical Trial Unit (ACTU), AIDS Vaccines Trials Network (VTN), 
Prevention Trials Network (PTN), and Terry Beirn Community Programs for 
Clinical Research on AIDS (CPCRA) programs, should describe how these programs 
are integrated with the proposed studies, if applicable, and should ensure 
that no scientific and budget overlap exists with the proposed project.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies and five copies of Appendix material in 
one package to:

BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)


Applications will be assigned on the basis of established NIH referral 
guidelines. Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures. As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, generally 
the top half of applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the appropriate national 
advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In the 
written comments reviewers will be asked to discuss the following aspects of 
the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application. Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score. For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) Significance: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive this 
(2) Approach: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications also will be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects also will be 
o The reasonableness of the proposed budget and duration in relation to the 
proposed research
o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.


Applications will compete for available funds with all other approved 
applications. The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding NIAID programmatic issues to:

Barbara Laughon, Ph.D.
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases 
6700 B Rockledge Drive, Room 5108, MSC 7624
Bethesda, MD 20892-7624
Telephone: (301) 402-2304
FAX: (301) 402-3171
Direct inquiries regarding NIAID programmatic issues specific to hepatitis C 
virus to:

Leslye D. Johnson, Ph.D.
Chief, Enteric and Hepatic Diseases Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 3109, MSC 7630
Bethesda, MD  20892-7630
Telephone:  (301) 496-7051
FAX:   (301) 402-1456

Direct inquiries regarding NIDA programmatic issues to:

Jag H. Khalsa, Ph.D.
Health Scientist Administrator
Center on AIDS & Other Medical
  Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse, NIH
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone: 301-443-1801 (443-2159 direct)
Fax: 301-443-4100

Direct inquiries regarding NIAAA programmatic issues to:

Thomas F. Kresina, PhD
Chief, Biomedical Research Branch
Institute AIDS Coordinator
National Institute on Alcohol Abuse & Alcoholism
Room 402, 6000 Executive Blvd
Bethesda, MD 20892-7003
Telephone: 301-443-6537
Fax: 301-594-0673 

Direct inquiries regarding NIDDK programmatic issues to:

Philip F. Smith, Ph.D.
Senior Advisor
Neuroendocrinology and Endocrinology of Obesity Research
Division of Diabetes, Endocrinology, and Metabolic Diseases
Natcher Building, Room 5AN-12C
BETHESDA MD 20892-6600
Telephone:  (301) 594-8816
Fax:  (301) 480-3503

Direct inquiries regarding NIMH programmatic issues to:

Dianne Rausch, Ph.D
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Blvd, Room 6209, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719

Direct inquiries regarding fiscal matters to:

Laura Eisenman
Division of Extramural Activities
6700-B Rockledge Drive, Room 2120, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-5541
FAX: (301) 402-2638


This program is described in the Catalog of Federal Domestic Assistance No. 
93.856 MID, 93.855 IA.  Awards are made under authorization of the Public 
Health Service Act Sections 301 and 406 of (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92. This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, and portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children. This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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