Administrative Supplements to Support Studies on Drug-Resistant HIV in Methamphetamine Abusers

Notice Number: NOT-DA-05-007

Key Dates
Release Date: March 24, 2005

Issued by
National Institute on Drug Abuse (NIDA), (


The National Institute on Drug Abuse (NIDA) has a long history of supporting research on the intertwined epidemics of drug abuse and HIV/AIDS and has a commitment to keeping abreast of the relevant science as these epidemics and their interrelationships evolve. For example, while injection drug use continues to be important factor in HIV transmission, sexual contact (both male-to-male and heterosexual) accounts for the majority of people living with HIV/AIDS in the U.S. Drugs of abuse are frequently involved in high-risk sexual behavior, but the association between drug use and high-risk sexual behavior seems to be particularly strong with methamphetamine. Methamphetamine abuse is not new; it has long been a major problem on the West Coast and in the Midwest and is now spreading across the country.

Recently, New York City public health officials reported a case of rapid disease progression following infection with a new strain of HIV-1 that is resistance to most anti-retroviral drugs. The patient from whom the new strain was isolated is an MSM who had abused crystal methamphetamine and engaged in high risk sex with multiple partners. Efforts are currently underway by NYC public health officials to trace this patient's sexual partners.

The combination of drug-resistance and rapid disease progression is unique. Typically disease progression is related to host immune system characteristics, but to date, no obvious host immunological factors have been identified the NYC patient that could account for the rapid disease progression. Even though the relationship between anti-retroviral drug resistance and disease progression has not been studied extensively, recent studies in patients receiving HAART therapy have not linked drug resistance with enhanced disease progression or death, which may be due to reductions in viral fitness associated with drug resistance mutations. However, unlike most drug-resistant strains, this new variant replicates well in vitro, and this virus is dual tropic for cells that express CCR5 or CXCR4 coreceptor.

While there have been many studies on methamphetamine and both injection and sexual HIV risk behavior, there is very little information on methamphetamine and HIV disease progression or on the prevalence of drug-resistant virus in methamphetamine abusers. However, increased HIV viral load due to reduced HAART effectiveness has been reported in methamphetamine users.

Given the potential public health significance of a drug resistant, virulent strain of HIV such as that reported in the NYC methamphetamine abuser, NIDA seeks to establish a targeted surveillance initiative to monitor the development of drug-resistant HIV in methamphetamine abusers. To facilitate gathering data rapidly, administrative supplements will be given to sample, collect, store, and analyze blood samples of cohorts with significant numbers of methamphetamine abusers and with available data on HIV risk behaviors, drug use histories, and indicators of immune function and/or disease progression.

Research Objectives

The intent of this initiative is to stimulate collaborative, multidisciplinary research to explore the emergence of drug-resistant strains of HIV in methamphetamine abusers whose risk behaviors are well characterized and to characterize these strains, including their replication-competence. It is hoped that these supplements will encourage researchers with expertise drug addiction and HIV behavioral, epidemiological, and treatment research to collaborate with researchers with expertise in infectious diseases, virology, and immunology. Funds are being made available for administrative supplements to existing NIDA-supported grants to take advantage of existing NIDA data sets to address an important public health issue.

Budget/Administrative Issues

For FY 2005, $750,000 will be available for administrative supplements to existing research projects. These administrative supplements are generally limited to 25 percent of the Council-approved direct costs for the current budget year of the project or $100,000, whichever is less. The existing grant must have at least one year remaining at the time that the supplement is awarded. Supplements may be requested for up to two years but may extend no longer than the parent grant. If two years of support are requested, the second year of requested support will also be limited to 25 percent of the Council-approved direct costs for the second year.

Administrative supplements will undergo program, grants management, and budget review within NIDA. The supplements will be evaluated on the 1) quality--what is the scientific merit of the project, 2) feasibility--can the project be conducted with the resources and within the timeframe proposed. Administrative supplements must be received by June 10, 2005. It is anticipated that supplemental funding will begin no later than September 30, 2005.

Application Procedure

Grantees wishing to apply for a supplement should submit an application that includes the following:

  1. A cover letter citing this NOTICE and requesting an administrative supplement;
  2. Page 1 of the PHS-398 grant application form, citing "Drug-Resistant HIV" in Line 2. Applicants must complete Page 1, and also include the signatures of the PI and an authorized institutional budget office official;
  3. A brief proposal describing the project, including:

a. An abstract
b. Budget with justifications
c. Biographical sketches of all key personnel
d. Specific Aims of the parent grant
e. Specific Aims of the supplemental project
f. A detailed description of the project including subject population, methods, and data analysis (less than 7 pages)
g. A discussion of future plans for expanding, extending, or otherwise continuing the research.

Send the original application and three copies to:

By U.S. Mail:
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda MD 20892-8403

By Express Mail:
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 242
Rockville MD 20852

Send one additional copy to:

By U.S. Mail:
National Institute on Drug Abuse
AIDS Research Program
6001 Executive Blvd.
Room 5274 MSC 9581
Bethesda, MD 20892-9581

By Express Mail:
National Institute on Drug Abuse
AIDS Research Program
6001 Executive Boulevard, Room 5274
Rockville MD 20852


For additional information or questions, please contact:

Jacques Normand, Ph.D.
Director, AIDS Research Program
National Institute on Drug Abuse
Telephone: (301) 443-1470
Fax: (301) 443-9127

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