This application is submitted on behalf of the ongoing HIV Malawi HIV Research Consortium (HRC) which includes the College of Medicine (COM) in Malawi, the University of North Carolina (UNC) at Chapel Hill, NC and the Johns Hopkins University (JHU) Bloomberg School of Public Health in Baltimore, MD. In recognition of the long history of these collaborations, JHU will continue to serve as the primary grantee institution and lead the Administrative Component of the proposed Clinical Trials Unit (CTU). This country-wide consortium includes the resources of the two main medical facilities in Malawi, the Queen Elizabeth Central Hospital in Blantyre and the Kamuzu Central Hospital in Lilongwe (they will represent the Clinical Research Sites). The HIV/AIDS epidemic is severely impacting the health of children, adolescents, men and women in Malawi. In some of these populations, the HIV prevalence is more than 30% and HIV incidence is more than 4 per 100 person-years. The Malawi HRC has developed a long-term collaboration focused on a wide spectrum of HIV research that includes most aspects of HIV prevention, HIV treatment and care and nascent vaccine efforts. This consortium has inspired several cutting-edge research projects and very extensive training and technology transfers. Each participating institution brings essential resources to this collaboration: the COM in Malawi provides a critical ink to all aspects of the health care infrastructure, appropriate patient populations, and in-country personnel required for a successful research program;Johns Hopkins University has provided leadership, training, clinical and laboratory resources, and a diverse scientific research agenda that led to innovative interventions;and UNC has provided access to new populations, increased capacity for biological research, pioneered research on sexually transmitted infections, and increased focus on issues of HIV treatment.
The Aims of this Proposal are I) To implement clinical trials that assess safety, efficacy and acceptability of appropriate interventions in all high priority research areas;II) To expand as needed to additional populations to further investigate HIV pathogenesis, evaluate the development of treatment and prevention strategies that are applicable to populations in resource-constrained settings, and respond to emerging scientific opportunities;and III) To work collaboratively with the Clinical Trials Networks Leadership to contribute to the scientific agenda. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069518-05
Application #
8010181
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Adedeji, Bola
Project Start
2007-02-15
Project End
2013-11-30
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
5
Fiscal Year
2011
Total Cost
$9,722,463
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Robertson, K; Jiang, H; Evans, S R et al. (2016) International neurocognitive normative study: neurocognitive comparison data in diverse resource-limited settings: AIDS Clinical Trials Group A5271. J Neurovirol 22:472-8
Derache, Anne; Wallis, Carole L; Vardhanabhuti, Saran et al. (2016) Phenotype, Genotype, and Drug Resistance in Subtype C HIV-1 Infection. J Infect Dis 213:250-6
Vardhanabhuti, Saran; Katzenstein, David; Bartlett, John et al. (2016) Human Immunodeficiency Virus-1 Sequence Changes and Drug Resistance Mutation Among Virologic Failures of Lopinavir/Ritonavir Monotherapy: AIDS Clinical Trials Group Protocol A5230. Open Forum Infect Dis 3:ofw154
Orlov, Marika; Smeaton, Laura M; Kumwenda, Johnstone et al. (2015) Presence of Plasmodium falciparum DNA in Plasma Does Not Predict Clinical Malaria in an HIV-1 Infected Population. PLoS One 10:e0129519
Firnhaber, Cynthia; Smeaton, Laura M; Grinsztejn, Beatriz et al. (2015) Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials 16:89-99
Thio, Chloe L; Smeaton, Laura; Hollabaugh, Kimberly et al. (2015) Comparison of HBV-active HAART regimens in an HIV-HBV multinational cohort: outcomes through 144 weeks. AIDS 29:1173-82
Shaffer, Douglas; Hughes, Michael D; Sawe, Fredrick et al. (2014) Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE). J Acquir Immune Defic Syndr 66:155-63
Wallis, Carole L; Aga, Evgenia; Ribaudo, Heather et al. (2014) Drug susceptibility and resistance mutations after first-line failure in resource limited settings. Clin Infect Dis 59:706-15
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60
Safren, Steven A; Biello, Katie B; Smeaton, Laura et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. PLoS One 9:e104178

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