Tuberculosis Trials Consortium (TBTC )

Department of Health and Human Services, Centers for Disease Control and Prevention, Office of Financial Resources, Office of Acquisition Services, 2900 Woodcock Blvd. Atlanta, GA 30341-4004 The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Division of Tuberculosis Elimination, Clinical Research Branch intends to negotiate sole source contract with the existing TBTC trail sites: 1. Case Western Reserve University, Cleveland, Ohio 2. John Hopkins University, Baltimore, MD 3. Regents of the University of California, San Francisco, San Francisco, CA 4. Denver Health & Hospitals Authority, Denver, CO 5. University of North Texas, Health Science Center, School of Public Health 6. Trustees of Columbia University, New York, NY The purpose of these contracts is to support ongoing clinical research activities for TBTC studies 31 and 37 in the treatment, diagnosis and prevention of tuberculosis (TB) throughout the one-year performance period 2019 -2020. TBTC Study 31 titled, "Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial". The primary objectives of this study are to evaluate the efficacy of a rifapentine-containing regimen 1) to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis, 2) that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis. TBTC Study 37 titled, "Six weeks of daily rifapentine vs. a comparator arm of 12-16 week rifamycin-based treatment of latent M. tuberculosis infection: assessment of safety, tolerability and effectiveness (ASTERoiD)." The primary objectives of this open-label Phase III clinical trial are to compare the safety and effectiveness of a six week regimen of daily rifapentine (6wP, the experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment of latent M. tuberculosis infection (LTBI). The latter will be the local standard of care rifamycin-based regimen. This trial will be conducted among persons with LTBI living in low to moderate tuberculosis (TB) incidence settings who are at increased risk of progression to TB and require treatment of LTBI. The use of other than full and open competition for this acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304 (a)(1) as set forth in Federal Acquisition Regulations, Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a Capability Statement demonstrating their abilities to meet this requirement. All responses will be considered. All Capability Statements shall be received by the closing date of this synopsis and shall be submitted in writing. Responses may be sent via email to luw9@cdc.gov. No solicitation will be issued. No telephone inquiries will be accepted.