This Durban CTU application is underpinned by a central administrative hub that serves the 3 HIV Clinical Research Sites included in this application. They bring together 3 major disciplines, most affected by the rising morbidity and mortality from HIV/AIDS viz. adult medicine, pediatrics, and obstetrics and gynecology from the University of KwaZulu-Natal, to develop and promote research into Translational Drug Research, Optimization of Clinical Management and Co-morbidities and to complement prevention and vaccine research programs in the region. The Principal Investigator, Prof. Umesh Lalloo, (also Site Leader for the Adult HIV Research Clinic) is supported by site experienced Site Leaders for the other research clinics proposed. Administration, Pharmacy, Lab Services and Data Management are the shared resources for all three sites. The long-term objectives are to: 1. Promote development of new strategies (drugs, immunomodulation, and regimens) to simplify the complex treatment of HIV/AIDS, given the immense impact of the epidemic in resource limited settings. This will ensure optimal treatment options in a Clade C HIV epidemic and where the threat of ARV drug resistance is serious and drug interactions are important, given the multiple co-morbidities 2. Promote the development of optimal strategies to treatment the complications of HIV, which contributes to the rising morbidity and mortality 3. Promote the development of scientific and clinical research expertise in resource limited settings in individuals from previously disadvantaged groups.

Public Health Relevance

The Province of KwaZulu-Natal has one the fastest growing HIV epidemics in the world and almost one in 3 adults and one in 15 children and infants are infected with HIV. The Clinical Trials Unit is unique because it includes infants, children and adults, and in particular has a research site that concentrates on health problems in HIV positive women, an area that is neglected in most HIV research programs. The epidemic has progressed to a stage where large numbers of people are experiencing complications of HIV and this Clinical Trials Unit will investigate translational drug research and optimal management strategies for common complications such as cryptococcal meningitis, tuberculosis, toxoplasmosis, viral hepatitis, pneumocystis, carinii pneumonia, and diarrhoeal diseases that cause considerable suffering and death.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-BLG-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Ukzn Innovation
South Africa
Zip Code
Hitti, Jane; Halvas, Elias K; Zheng, Lu et al. (2014) Frequency of Antiretroviral Resistance Mutations among Infants Exposed to Single-Dose Nevirapine and Short Course Maternal Antiretroviral Regimens: ACTG A5207. J AIDS Clin Res 5:
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
McMahon, Deborah K; Zheng, Lu; Hitti, Jane et al. (2013) Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV. Clin Infect Dis 56:1044-51
Lockman, Shahin; Hughes, Michael; Sawe, Fred et al. (2012) Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med 9:e1001236
Campbell, Thomas B; Smeaton, Laura M; Kumarasamy, N et al. (2012) Efficacy and safety of three antiretroviral regimens for initial treatment of HIV-1: a randomized clinical trial in diverse multinational settings. PLoS Med 9:e1001290
Ribaudo, Heather J; Benson, Constance A; Zheng, Yu et al. (2011) No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT. Clin Infect Dis 52:929-40
Grinsztejn, Beatriz; Smeaton, Laura; Barnett, Ronald et al. (2011) Sex-associated differences in pre-antiretroviral therapy plasma HIV-1 RNA in diverse areas of the world vary by CD4(+) T-cell count. Antivir Ther 16:1057-62
Grady, Benjamin J; Torstenson, Eric S; McLaren, Paul J et al. (2011) Use of biological knowledge to inform the analysis of gene-gene interactions involved in modulating virologic failure with efavirenz-containing treatment regimens in ART-naïve ACTG clinical trials participants. Pac Symp Biocomput :253-64