The proposed Stellenbosch University Clinical Trial Unit (SU CTU) is located at Tygerberg Academic Hospital, a tertiary care centre in Cape Town, South Africa. The metropolitan region has a high prevalence of HIV (13% of women attending antenatal clinics) and also a high incidence of tuberculosis (>600 new cases/100 000 population). ? ? The SU CTU has three Clinical Research Sites (CRS) that operate in a well integrated fashion and an established referral system from regional hospitals, community health clinics and mid-wife obstetric units. The Children's Infectious Diseases (KIDCRU) CRS and the Prevention of Mother-to-Child Transmission (PMTCT) CRS were established through the Pediatric AIDS Clinical Trial Group (PACTG) and presently recruiting subjects into three transition studies (2 pediatric and 1 PMTCT). One pediatric study determines the role of isoniazid in preventing tuberculosis (P1041). The PMTCT study addresses the optimal time for HIV testing for pregnant women presenting for labor (P1031). Both studies will accrue subjects in the transition phase in excess of the 20 patient average per month required for each site. The KIDCRU CRS is planning two additional transition studies: 1. Antiretroviral (ARV) strategy trial which will provide critical information for the national ARV program (P390) and, 2. Hepatitis B vaccine study for adolescents, which will provide useful information and a nucleus for an adolescent research program (ATN024). The KIDCRU CRS; and PMTCT CRS have been invited to affiliate with the IMPAACT Network. The SU CTU has the support of expert consultants in adolescence, neonatology, childhood TB and pediatric neurology from the SU Faculty of Health Sciences, who will contribute to protocol development and study implementation. The third site is an Adult infectious Diseases Clinical Research Site (AIDs CRS). Although not yet affiliated with a HIV/AIDS network, its investigators have a track record of conducting ARV trials for industry and initiating a trial comparing two non-nucleoside reverse transcriptase inhibitors as a third component of ARV therapy. This CRS proposes an optimization study of immediate versus deferred initiation of antiretroviral therapy for HIV+ adults treated for tuberculosis (AACTG A5221). A co-mentoring partnership will be established with Dr. Thomas Campbell from the Colorado AIDS CTU, University of Colorado, and Prof. James Mclntyre, Perinatal HIV Research Unit ACTG, Witwatersrand University. Though this co-mentoring partnership, the AIDs CRS is expected to be able to enroll subjects within six months of funding. ? ? ADMINISTRATIVE COMPONENT: ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI069521-01
Application #
7097842
Study Section
Special Emphasis Panel (ZAI1-MPM-A (M2))
Program Officer
Germuga, Donna E
Project Start
2007-04-15
Project End
2014-01-31
Budget Start
2007-04-15
Budget End
2008-01-31
Support Year
1
Fiscal Year
2007
Total Cost
$1,678,426
Indirect Cost
Name
Stellenbosch University Tygerberg Campus
Department
Type
DUNS #
569118040
City
Tygerberg
State
Country
South Africa
Zip Code
7505
Innes, Steve; van Toorn, Ronald; Otwombe, Kennedy et al. (2017) Late-Onset Hiv Encephalopathy In Children With Long-Standing Virologic Suppression Followed By Slow Spontaneous Recovery Despite no Change In Antiretroviral Therapy: 4 Case Reports. Pediatr Infect Dis J 36:e264-e267
Sy, Sherwin K B; Malmberg, Ruben; Matsushima, Aoi et al. (2015) Effect of reducing the paediatric stavudine dose by half: a physiologically-based pharmacokinetic model. Int J Antimicrob Agents 45:413-9
Nachega, Jean B; Parienti, Jean-Jacques; Uthman, Olalekan A et al. (2014) Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis 58:1297-307
Streicher, Elizabeth M; Maharaj, Kashmeel; York, Talita et al. (2014) Rapid sequencing of the Mycobacterium tuberculosis pncA gene for detection of pyrazinamide susceptibility. J Clin Microbiol 52:4056-7
Nachega, Jean B; Uthman, Olalekan A; del Rio, Carlos et al. (2014) Addressing the Achilles' heel in the HIV care continuum for the success of a test-and-treat strategy to achieve an AIDS-free generation. Clin Infect Dis 59 Suppl 1:S21-7
Sy, Sherwin K B; Innes, Steve; Derendorf, Hartmut et al. (2014) Estimation of intracellular concentration of stavudine triphosphate in HIV-infected children given a reduced dose of 0.5 milligrams per kilogram twice daily. Antimicrob Agents Chemother 58:1084-91
van Zyl, Gert U; Frenkel, Lisa M; Chung, Michael H et al. (2014) Emerging antiretroviral drug resistance in sub-Saharan Africa: novel affordable technologies are needed to provide resistance testing for individual and public health benefits. AIDS 28:2643-8
Uthman, Olalekan A; Magidson, Jessica F; Safren, Steven A et al. (2014) Depression and adherence to antiretroviral therapy in low-, middle- and high-income countries: a systematic review and meta-analysis. Curr HIV/AIDS Rep 11:291-307
Innes, Steve; Lazarus, Erica; Otwombe, Kennedy et al. (2014) Early severe HIV disease precedes early antiretroviral therapy in infants: Are we too late? J Int AIDS Soc 17:18914
Cotton, Mark F; Rabie, Helena (2014) Universal children's day--let's improve current interventions to reduce vertical transmission of HIV now. J Int AIDS Soc 17:19875

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