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Stellenbosch University Clinical Trial Unit, Cape Town, South Africa

Summary

Principal Investigator: Mark F Cotton
Affiliation: University of Stellenbosch
Country: South Africa
Abstract: 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:
Funding Period: 2007-04-15 - 2014-01-31
more information: NIH RePORT

Top Publications

  1. pmc High prevalence of lipoatrophy in pre-pubertal South African children on antiretroviral therapy: a cross-sectional study
    Steve Innes
    Department of Paediatrics, Children s Infectious Diseases Clinical Research Unit KID CRU, Tygerberg Children s Hospital, Stellenbosch University, Cape Town, South Africa
    BMC Pediatr 12:183. 2012
  2. pmc Biceps skin-fold thickness may detect and predict early lipoatrophy in HIV-infected children
    Steve Innes
    Children s Infectious Diseases Clinical Research Unit, Tygerberg Children s Hospital, and Department of Paediatrics, Stellenbosch University, Cape Town, South Africa
    Pediatr Infect Dis J 32:e254-62. 2013
  3. pmc Estimation of intracellular concentration of stavudine triphosphate in HIV-infected children given a reduced dose of 0.5 milligrams per kilogram twice daily
    Sherwin K B Sy
    Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida, USA
    Antimicrob Agents Chemother 58:1084-91. 2014
  4. pmc Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials
    Jean B Nachega
    Department of Epidemiology, Pittsburgh University Graduate School of Public Health, Pennsylvania
    Clin Infect Dis 58:1297-307. 2014

Detail Information

Publications8

  1. pmc High prevalence of lipoatrophy in pre-pubertal South African children on antiretroviral therapy: a cross-sectional study
    Steve Innes
    Department of Paediatrics, Children s Infectious Diseases Clinical Research Unit KID CRU, Tygerberg Children s Hospital, Stellenbosch University, Cape Town, South Africa
    BMC Pediatr 12:183. 2012
    ..Lipoatrophy in sub-Saharan African children can be stigmatizing and have far-reaching consequences. The severity and extent of lipoatrophy in pre-pubertal children living in sub-Saharan Africa is unknown...
  2. pmc Biceps skin-fold thickness may detect and predict early lipoatrophy in HIV-infected children
    Steve Innes
    Children s Infectious Diseases Clinical Research Unit, Tygerberg Children s Hospital, and Department of Paediatrics, Stellenbosch University, Cape Town, South Africa
    Pediatr Infect Dis J 32:e254-62. 2013
    ..Early diagnosis of lipoatrophy is essential for effective intervention to arrest progression...
  3. pmc Estimation of intracellular concentration of stavudine triphosphate in HIV-infected children given a reduced dose of 0.5 milligrams per kilogram twice daily
    Sherwin K B Sy
    Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida, USA
    Antimicrob Agents Chemother 58:1084-91. 2014
    ..8 to 28.6 fmol/10(6) cells), respectively. Halving the current standard pediatric dose should therefore not compromise antiviral efficacy, while markedly reducing mitochondrial toxicity. ..
  4. pmc Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials
    Jean B Nachega
    Department of Epidemiology, Pittsburgh University Graduate School of Public Health, Pennsylvania
    Clin Infect Dis 58:1297-307. 2014
    ..We performed a meta-analysis of randomized controlled trials (RCTs) to investigate the impact of pill burden and once-daily vs twice-daily dosing on ART adherence and virological outcomes...