Response requested April 10, 2015.
The National Institute on Drug Abuse published RFI NOT-DA-15-052 seeking information about the availability of data from biological specimens (such as blood, plasma, isolated cells [PBMCs]) obtained from HIV Infected and non-infected injection drug using (IDU) subjects. This information will be used to determine the feasibility of developing programs for conducting genetic and epigenetic analyses of data on the host-response to HIV and modalities of personalized (precision) medicine for treating HIV infection in IDUs.
Drug addiction is a major factor in driving the AIDS and hepatitis C epidemics. Globally, an estimated 16 million people inject drugs and 3 million of them are living with HIV. On average one out of every ten new HIV infections is caused by injection drug use; in parts of Eastern Europe and Central Asia, over 80% of all HIV infections is related to drug use (WHO; http://www.who.int/hiv/topics/idu/en/). Further, up to 90% of HIV infected IDUs may also be infected with hepatitis C.
While a large number of clinical samples have been collected from HIV-infected and non-infected drug abusing patients/subjects over the past 30 years, the number and type of basic and clinical information from biological specimens (blood, plasma, isolated cells such as PBMCs etc.) is not known. The earlier successes of the 1200 genome wide association studies (GWAS identifying variants for more than 200 diseases and traits, is frequently dependent on the development of consortia to generate sufficient power to detect gene variants. Thus, knowledge about the number and type of available data and bio-specimens is needed to make informed decision about the feasibility of developing programs for conducting genetic and epigenetic analysis of injecting drug use, the host-response to HIV, and models of (personalized) precision medicine for treating HIV infection and injection drug use.
If you have clinical data and bio-specimens from HIV- and Non-infected HIV Injection Drug Users, we request that you provide information about the clinical data and bio-specimens. We request that you provide this information to us by April 10, 2015. Your comments can include but are not limited to the following examples of the type of information that would be helpful : 1) The principle Investigator and Assistant contact information; 2) patient information: (i) type and number of bio-specimens collected; (ii) HIV and HCV status (iii) viral load, CD4 count, (iv) clinical assessment including standard blood work-up for metabolic and hepatic panels; and finally (v) treatment status: antiretroviral regimen used .
Clinical data about substance abuse might include: i) onset (early versus late) of drug use, the amount, frequency, pattern (binge or escalated use), type of drug used, route of drug administration, and amount of money spent; (ii) biomarker used to quantity the drug use; iii) DSMIII-R and DSMIV symptoms; iv) measures of withdrawal severity such as the Clinical Opiate Withdrawal Scale (COWS) or other measures of withdrawal for other substances; v) time spent seeking a drug; vi) duration of abstinence; vii) number of quit attempts; viii) other co-morbid psychiatric disorders; ix) environmental variables; x) instruments used to assess substance use; and xi) the method of sample collection.
Other information that would be helpful is whether the research participants are consented for genetic studies or can be re-contacted to obtain consent, and whether a whole genome association scan has been performed on the research participant. If a genome wide scan has been performed, please provide the platform used and the where the genotypic and phenotypic data can be located.
Submitting a Response
All responses must be submitted via email to NIDAInjectionDrugUse@mail.nih.gov by April 10, 2015. Please include the Notice number in the subject line. Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above. The submitted information will be reviewed by the NIH staff.
This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be aggregated in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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