Introduction

This site was established in 2001 and officially opened in September 2003, as a research unit for prospective clinical trials. The mission is to perform research in infectious diseases to the benefit of children and their families. The major focus is on HIV and tuberculosis, diseases of major significance to patients attending our hospital. KID-CRU collaborates with other South African institutions both in the Western Cape and Gauteng. We are externally funded by mainly the Division of AIDS, National Institutes of Health (NIH), USA and also the Rockefeller Foundation. The funding specifically relates to trial related management. As our focus is HIV and TB, the capacity of the hospital to manage these conditions is enhanced.
The different clinical trials that we do are the following:

NIH programs

IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials Group) Study

This is funded by NIH-USA and Secure the Future. The Regulatory body is DAIDS (Division of AIDS). Clinical trials are done in several countries eg. RSA, Thailand, Brasil, all over USA. South Africa has 3 sites currently: Cape Town (Tygerberg Hospital); Johannesburg and Durban.

The Tygerberg hospital site is administrated by the University of Stellenbosch.
IMPAACT provides all resources and financial support to do the clinical trials.
We are currently doing 3 studies at the Tygerberg site (2 x Paediatric clinical trials and 1 x perinatal trial).

CIPRA (Comprehensive Program for Research in AIDS)

Our unit is collaborating with the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital and Desmond Tutu Center for HIV Research, University of Cape Town to conduct 4 interlinking studies. Project 2 - CHER is a trial comparing three treatment strategies in infants with perinatally acquired HIV-1 infection diagnosed between 6 and 12 weeks of age. Project 4 is a comparative study which will evaluate the safety and efficacy of a pneumococcal vaccine (PncCV) and a Haemophyllis Influenza vaccine.

ATN (Adolescent Trials Network)

A Multi-Center Trial (ATN024i) of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), sponsored by 'The National Institute of Child Health and Human Development (NICHD)', is taking place at KID CRU. This is the first adolescent trial the unit is conducting.

Other projects

Rockefeller Study

Tuberculosis (TB) , a frequent infection in HIV-infected African children, increases the progression of HIV infection. The effect of isoniazid (INH) prophylaxis on mortality and TB incidence in HIV infected children has not been studied.

The aim of the Rockefeller study is to investigate the effect of INH prophylaxis on mortality and TB incidence in HIV-infected children from a high TB prevalence area.

In addition, trimethoprim-sulphamethoxazole (Bactrim) is given in conjunction with the INH either daily or three times a week in order to evaluate the effect on mortality and morbidity in HIV- infected children.

APO

Apoptosis assays are conducted in heparinized blood samples. This study is to investigate whether measuring the life cycle of white blood cells from patients with various diseases and infected with HIV, in the test tube, can be used to see if the medicines are working well.

Other Studies

There are other smaller studies at KID CRU. 'Chronic Lung Disease in Children with HIV Infection' and 'The determination of Nevirapine plasma concentrations in premature infants' are 2 important studies which is being done in cooperation with other doctors from Tygerberg Hospital. A trial to investigate the Pharmacokinetic safety of TMC114/rtv has also been implemented at the site by Tibotec.