The mission of the AIDS Clinical Trials Group (ACTG) is to develop and conduct scientifically rigorous translational research and therapeutic clinical trials to: 1) investigate the viral and immune pathogenesis of HIV-1 infection and its complications;2) evaluate novel therapeutic agents and the most effective approaches and strategies for the use of existing agents to treat HIV-1 infection;3) evaluate interventions and strategies to treat and prevent HIV-related opportunistic infections, co-infections, complications of therapies, and other HIV-1-related co-morbidities, and 4) publish and disseminate the findings from these studies for the purpose of improving clinical care, preventing or delaying HIV disease progression, and reducing or eliminating the morbidity and mortality associated with HIV-1 infection and its associated complications. In this application the ACTG proposes a comprehensive, integrated clinical and translational research program that addresses five of the six scientific areas outlined under this RFA: 1) Translational Research and Drug Development;2) Optimization of Clinical Management, including Co-Infection;3) Vaccine Research and Development;4) Prevention of Mother to Child Transmission, and 5) Prevention of HIV Infection. An Oral Health program will be undertaken in collaboration with investigators supported by the National Institute of Dental and Craniofacial Research. This program will be conducted in collaboration with the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HPTN), the IMPAACT network and the Microbicide Trials Network (MTN). The proposed research agenda as well as the Group Leadership and organizational structure reflect the worldwide impact of the HIV epidemic. We propose to conduct the work using a network of 72 clinical research sites in the United States and 12 countries in Africa, Asia, Latin America and the Caribbean. The network is actively supported by an integrated network of Core Laboratories with broad expertise in virology, pharmacology, immunology, and genomics. The ACTG Operations Center, located in Silver Spring, MD, provides key operational, administrative, and fiscal support. Statistical expertise and data management resources are provided by the Statistics and Data Management Center in Boston, MA and Buffalo, NY. CORE (P.I. Benson, Constance) CORE: Translational Research/Drug Development

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-TS-A (J1))
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Ojumu, Akinlolu O
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Brigham and Women's Hospital
United States
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Schnitzer, Mireille E; Lok, Judith J; Bosch, Ronald J (2016) Double robust and efficient estimation of a prognostic model for events in the presence of dependent censoring. Biostatistics 17:165-77
Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209
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Rutstein, Sarah E; Hosseinipour, Mina C; Weinberger, Morris et al. (2016) Predicting resistance as indicator for need to switch from first-line antiretroviral therapy among patients with elevated viral loads: development of a risk score algorithm. BMC Infect Dis 16:280
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Shivakoti, Rupak; Christian, Parul; Yang, Wei-Teng et al. (2016) Prevalence and risk factors of micronutrient deficiencies pre- and post-antiretroviral therapy (ART) among a diverse multicountry cohort of HIV-infected adults. Clin Nutr 35:183-9
Castillo-Mancilla, Jose R; Aquilante, Christina L; Wempe, Michael F et al. (2016) Pharmacogenetics of unboosted atazanavir in HIV-infected individuals in resource-limited settings: a sub-study of the AIDS Clinical Trials Group (ACTG) PEARLS study (NWCS 342). J Antimicrob Chemother 71:1609-18
Bekker, A; Schaaf, H S; Draper, H R et al. (2016) Pharmacokinetics of Rifampin, Isoniazid, Pyrazinamide, and Ethambutol in Infants Dosed According to Revised WHO-Recommended Treatment Guidelines. Antimicrob Agents Chemother 60:2171-9
Bedimo, Roger; Kang, Minhee; Tebas, Pablo et al. (2016) Effects of Pegylated Interferon/Ribavirin on Bone Turnover Markers in HIV/Hepatitis C Virus-Coinfected Patients. AIDS Res Hum Retroviruses 32:325-8

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