SPECIAL NOTICE
B -- Investigation to examine hypothesis that malabsorption of antiberculosis medications in association with adverse outcomes in persons with HIV and TB
- Notice Date
- 11/28/2006
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 2007-Q-09221
- Response Due
- 12/6/2006
- Archive Date
- 12/21/2006
- Description
- The Centers for Disease Control and Prevention, National Center for HIV, Hepatitis, STD, and Tuberculosis Prevention, Division of Tuberculosis Elimination intends to award a sole source contract under Simplified Acquisition procedures to the National Jewish Medical and Research center, 1400 Jackson Street, Denver, Colorado 80206, the only source that has access to a significant proportion of serological specimens from an ongoing study of laboratory specimens in collaboration with CDC that were not completed. The period of performance is 2 months from date of award. The purpose of this effort is to examine the hypothesis that malabsorption of anti-tuberculosis medications, specifically isoniazid, rifampin, ethambutol, and pyrazinamide) is associated with adverse outcomes in persons with HIV and TB. This is not a request for competitive proposals and no solicitation is available. A determination by the Government not to compete this proposed action based on response to this notice is solely with the discretion of the Government. Information received will be considered solely for the purpose of determining to conduct a competitive procurement. Minimum requirements. (a) Prior experience in collaborating with the CDC on the investigation of malabsorption of anti-tuberculosis medications. (b) Experience and expertise in analyzing serum specimens by HPLC methodology, for anti-tuberculosis medication levels and pharmokinetics. (c) History of performing quality-assured HPLC analyses of serum specimens for anti-tuberculosis medication levels and pharmokinetics. (d) History of working to deadlines and providing interim deliverables Extensive knowledge and publication history (in peer-reviewed journals) of anti-tuberculosis medication pharmokinetics. (e) Registered in the Central Contractor Registration (CCR). Contractors may register by calling 1-888-227-2423 or register via the Internet at www.ccr.gov. Notification of any changes shall be made only through FedBizOpps, http://www.fedbizopps.gov. The NAICS code is 541990. Quotes may be faxed to (404) 639-8095, ATTN: Mrs. Johnson or emailed to chj5@cdc.gov. The date specified for receipt of offer is December 6, 2006 12:00 p.m. EST. STATEMENT OF WORK Requisition Malabsorption of Anti-Tuberculosis Medications in Botswana ? Statement of Work Division of Tuberculosis Elimination I. BACKGROUND Recent epidemiologic investigations have raised concerns regarding the role of drug malabsorption in the development of resistance to and subsequent efficacy of anti-tuberculosis drugs in HIV-infected patients. A previous case-control study in San Francisco suggests that HIV infection and gastrointestinal symptoms are independent risk factors for the emergence of drug-resistance, and thus may impact the efficacy of anti-tuberculosis therapies. Other examples of poor clinical outcomes following the completion of standard therapy have occurred in HIV-infected persons who have been compliant with therapy. In a population-based molecular epidemiology study in San Francisco, TB relapse cases were found to not be the result of exogenous re-infection, but from prior infection. In the case-control study, many of the HIV patients who developed adverse outcomes had gastrointestinal illnesses that may have resulted in malabsorption. This investigation will examine the hypothesis that malabsorption of anti-tuberculosis medications, specifically isoniazid, rifampin, ethambutol, and pyrazinamide) is associated with adverse outcomes in persons with HIV and TB. To investigate this hypothesis we will measure the prevalence of malabsorption of anti-tuberculosis drugs, as reflected in serum pharmacokinetic parameters, and determine if these parameters are associated with increased rates of TB treatment failure and relapse after the completion of therapy. The specific aims of this evaluation are: 1. To measure the prevalence of the malabsorption of isoniazid, rifampin, ethambutol, and pyrazinamide, as reflected in serum pharmacokinetics parameters measured using high performance liquid chromatography (HPLC), in patients with pulmonary TB in Gaborone, Botswana 2. To delineate characteristics of patients who have malabsorption of anti-tuberculosis drugs, based on an analysis of historical, clinical, and laboratory data, and HIV serostatus. 3. To determine the rate of and risk factors for TB treatment failure at the completion of conventional short-course therapy and the rate of TB relapse in the 18 months following the completion of conventional short-course therapy. 4. To explore the relationship between adverse clinical outcomes, other risk factors (including the malabsorption of anti-tuberculosis drugs) and polymorphic human genes such as Class I and Class II HLA, the Vitamin D receptor, and tumor necrosis factor. In light of the high mortality rates seen among HIV-infected TB patients in sub-Saharan Africa, the current extent of the TB/HIV epidemic worldwide, and the increasing identification of extensively drug-resistant (XDR) TB strains, we believe this study may provide critical information in establishing the role of malabsorption of anti-tuberculosis medications on clinical outcome. As such, we are submitting this statement of work with the intention of completing laboratory analyses of the 742 existing, unprocessed, and de-identified serum specimens collected during the original study. A portion of these 742 specimens is being stored at the CASPIR facility In Lawrenceville, Georgia and the remaining portion of specimens is being stored at National Jewish Medical Center in Denver, Colorado. II. PURPOSE To acquire the services of a vendor who has: (a) Prior experience in collaborating with the CDC on the investigation of malabsorption of anti-tuberculosis medications (b) Experience and expertise in analyzing serum specimens by HPLC methodology, for anti-tuberculosis medication levels and pharmokinetics (c) Established quality assurance in regards to laboratory processing techniques (d) Ability to analyze specimens, and report results of analyses, in a timely manner. III. SCOPE OF WORK The vendor will receive from the CASPIR facility in Lawrenceville, Georgia and National Jewish Medical and Research Center in Denver, Colorado, the 742 serum specimens, appropriately packaged and aliquot for analysis, and will perform HPLC analysis of each sample to determine the levels of isoniazid, rifampin, ethambutol and pyrazinamide. IV. TASKS Activities from the date of award for a 2-month period: The vendor will assist CDC with activities necessary for the determination of serum anti-tuberculosis medication levels by means of the following: 1) Use of established, study-specific definitions for the determination of ?low? and ?very-low? levels of isoniazid, rifampin, ethambutol and pyrazinamide. 2) Provide HPLC analysis of all serum specimens to determine the levels of isoniazid, rifampin, ethambutol and pyrazinamide. 3) Report of serum drug levels, in the form of an electronic Excel file and as a written paper report, the results of these analyses to the CDC within 2 weeks after receipt of all specimens. 4) Collaborate with colleagues from CDC in the incorporation and final analyses of these laboratory results into the overall study. V. PERIOD OF PERFORMANCE The period of performance shall begin on the date of award and be completed within a 8-week period. VI. DELIVERABLES The vendor shall provide the following deliverables to the Project Officer by the dates shown below: 1) Report of serum isoniazid, rifampin, ethambutol and pyrazinamide levels of all study participants for whom serum samples were received i. Two weeks after receipt of serum specimens 2) Written, detailed narrative, of approximately 5 pages length, of the results of final data analysis. This narrative should include drug levels for each specimen as well as calculated pharmacokinetic half-lives for each specimen series. IX. MINIMUM VENDOR QUALIFICATIONS a) History of performing quality-assured HPLC analyses of serum specimens for anti-tuberculosis medication levels and pharmokinetics. b) History of working to deadlines and providing interim deliverables c) Extensive knowledge and publication history (in peer-reviewed journals) of anti-tuberculosis medication pharmokinetics Instructions to Bidders I. Relevant Experience Please provide a description of each contract/assignment completed in the past 3-5 years relevant and similar to that in the statement of work contained herein. Please provide the name/address and point of contact for each customer. This section shall not exceed 3 pages. II. Technical Approach Please provide a one page summary of proposed approach to completing the proposed work. Please address understanding of requirements, target audience, subject matter and specific considerations/techniques proposed. III. Personnel Please provide a curriculum vitae/resume for each individual expected to provide 20% or more of the labor under order. Please address education, work experience and any relevant training of the individual. Please explain the role each individual is to play in completing the statement of work. IV. Past Performance Please provide a list of references that can validate the quality of performance on prior similar work. Include references for work listed in item I. above, in addition to any others. Please provide the following for each reference, not to exceed a total of five: Name; Employer; Address; Telephone Number/E-mail address; Description of work for which they are provided as a reference and individual?s role. V. Budget Provide a budget for the proposed work Labor: Include labor rate and number of hours for each individual proposed under the order. Other Direct Costs: List any non-labor costs associated with the work, such as travel, supplies, etc. Total Cost: Labor plus Other Direct Costs
- Place of Performance
- Address: Centers for Disease Control and Prevention, 8 Corporate Square, Atlanta, GA
- Zip Code: 30329-1902
- Country: UNITED STATES
- Zip Code: 30329-1902
- Record
- SN01187090-W 20061130/061128220141 (fbodaily.com)
- Source
-
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