[afro-nets] Clinical research in HIV/AIDS

[Omololu Falobi <omololu@nigeria-aids.org>]

Clinical research in HIV/AIDS prevention, vaccine and treatment
research and development
---------------------------------------------------------------

For your interest:

PRESS RELEASE:

National Institute of Allergy and Infectious Diseases
National Institutes of Health

Media Contact: NIAID News Office
+1-301-402-1663
mailto:niaidnews@niaid.nih.gov

NIAID SEEKS APPLICANTS TO LEAD CLINICAL TRIALS UNITS FOR RE-
VAMPED HIV/AIDS NETWORKS

The National Institute of Allergy and Infectious Diseases
(NIAID) announced that it is soliciting applications from U.S.
and overseas research institutions seeking to become Clinical
Trials Units (CTUs) in the Institute's revamped HIV/AIDS Clini-
cal Trials Networks. NIAID, part of the U.S. National Institutes
of Health (NIH), supports the world's largest portfolio of
clinical research in HIV/AIDS prevention, vaccine and treatment
research and development.

This solicitation, the second of two Requests for Applications
(RFAs), is designed to increase the efficiency, accountability
and integration of NIAID's HIV/AIDS clinical research networks
and enhance their capacity to effectively conduct vital clinical
research, especially in resource-limited settings.

The first solicitation, "Leadership for HIV/AIDS Clinical Trials
Networks," was released in November 2004. The networks emerging
from that RFA will focus on developing and evaluating treat-
ments, prevention strategies and vaccines, with an emphasis on
interventions that can be employed in resource-limited settings.
The Clinical Trials Units funded in response to this RFA will
carry out the research agendas of those networks in one or more
of the following six priority areas of investigation:

* Developing HIV vaccines

* Translating research insights into therapies to treat HIV dis-
ease

* Optimizing clinical management of HIV/AIDS, including co-
infections and other HIV-related conditions

* Developing microbicides to prevent HIV acquisition and/or
transmission

* Preventing mother-to-child transmission of HIV

* Developing other methods of HIV prevention

"These Clinical Trials Units will help coordinate and carry out
the next generation of AIDS research in the United States and
globally," says NIAID Director Anthony S. Fauci, M.D. "Our goal
is to develop the best possible leadership and research infra-
structure to carry out a flexible, collaborative and coordinated
approach to HIV vaccine, prevention and treatment research."

Funding for both the Network Leadership and the Clinical Trials
Units is expected to total up to $300 million for the first year
and may continue for up to seven years. The earliest anticipated
award date for the Leadership RFA is March 2006; Clinical Trials
Units RFA awards are estimated to be made in mid- to late 2006.

Each Clinical Trials Unit will be led by a principal investiga-
tor and will comprise an administrative component and one or
more clinical research sites. NIAID strongly encourages the es-
tablishment of CTUs that reach populations most affected or
threatened by the HIV/AIDS epidemic in the United States and
abroad, especially women, adolescents and people of color.

"The success of the restructured HIV/AIDS clinical networks will
require the commitment of diverse institutions, an unprecedented
degree of collaboration, and the involvement and support of com-
munities affected by HIV/AIDS in the United States and around
the world," notes Dr. Fauci.

The updated clinical research structure envisioned in the two
RFAs emerged through extensive consultations with researchers,
clinicians, nurses, community leaders, advocates and people liv-
ing with and at risk for HIV/AIDS.

Application Information

Any public or private institution or organization, governmental
or non-governmental, for-profit or nonprofit, can submit an ap-
plication in response to the Clinical Trials Units RFA. These
organizations, which can be domestic or foreign, may include
universities, colleges, hospitals, private and group medical
practices, units of state and local government, eligible agen-
cies of the U.S. federal government and non-governmental agen-
cies.

Pre-application meetings devoted to a comprehensive overview of
application submission requirements for the Clinical Trials
Units RFA are taking place at venues in the United States and
abroad. The first day of each meeting will consist of a grant-
writing workshop designed to build an understanding of the NIH
grant application process and provide information on how to de-
velop a grant application. The second day will feature an over-
view of application requirements, procedures and the review
process. Meetings will be held in the following cities:

* Bethesda, MD (March 7-8, 2005)
* Miami, FL (March 17-18, 2005)
* Johannesburg, South Africa (March 31-April 1, 2005)
* Bangkok, Thailand (April 20-21, 2005)

Copies of the RFA for Clinical Trials Units for HIV/AIDS Clini-
cal Trials Networks can be obtained at
http://www.niaid.nih.gov/daids/rfa/network06
Information on pre-application meeting location, logistics and
registration is available at http://www.blsmeetings.net/ctu.

Please note that while some informational materials regarding
this announcement are made available in other languages, the RFA
and accompanying materials are only available and must be com-
pleted in English.

NIAID is a component of the National Institutes of Health, an
agency of the U.S. Department of Health and Human Services.
NIAID supports basic and applied research to prevent, diagnose
and treat infectious diseases such as HIV/AIDS and other sexu-
ally transmitted infections, influenza, tuberculosis, malaria
and illness from potential agents of bioterrorism. NIAID also
supports research on transplantation and immune-related ill-
nesses, including autoimmune disorders, asthma and allergies.

News releases, fact sheets and other NIAID-related materials are
available on the NIAID Web site at http://www.niaid.nih.gov

_____________________________________

JOHANNESBURG PRE-APPLICATION MEETING:

HIV/AIDS CLINICAL TRIALS UNITS (CTUs) FUNDING OPPORTUNITY

U.S. National Institute for Allergy and Infectious Diseases

A pre-application meeting will be held in Johannesburg, South
Africa for representatives of institutions that would like to
learn more about the Request for Applications (RFA) to establish
Clinical Trials Units (CTUs) as part of the HIV/AIDS Clinical
Trials Networks of the U.S. National Institutes of Health's Di-
vision of AIDS (NIH/DAIDS).

U.S.- and foreign-based, public or private, for-profit or non-
profit entities are eligible to respond to this solicitation,
the second of two RFAs that will restructure NIAID's HIV/AIDS
Clinical Trials Networks to better conduct and coordinate AIDS
research. The first RFA, released in November 2004, will estab-
lish Leadership for the Clinical Trials Networks.

Potential CTU applicants are invited to attend one or both days
of the pre-application meeting in Johannesburg. The first day of
the meeting will consist of an NIH grant-writing workshop. The
second day will feature an overview of CTU application require-
ments, procedures and the review process.

Johannesburg, South Africa (March 31-April 1, 2005)
3/31 - Grant-writing workshop
4/1 - Pre-application meeting

Both days of the meeting will be held at:
Holiday Inn Garden Court
Johannesburg International Airport
2 Hulley Road
Kempton Park
South Africa

Meeting registration should be made through
http://www.blsmeetings.net/ctu.

Details on the Clinical Trials Networks restructuring (including
the full text of both RFAs), French versions of the CTU RFA
press release and pre-application meeting flyer, and information
for individuals with disabilities who wish to participate in the
meeting are available at
http://www.niaid.nih.gov/daids/rfa/network06.

Any questions about the CTU RFA should be directed to
mailto:FY06CTURFA@niaid.nih.gov