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Program: Concurrent treatment in TB and HIV co-infection
  • Title (NL) Simultane behandeling van co-infecties van tuberculose en HIV
  • Period 06 / 2006 - 08 / 2010
  • Status Current
Abstract
bullet Abstract Tuberculosis (TB) is a major health problem in sub-Saharan Africa and has resurged dramatically since HIV came into Africa. In the Kilimanjaro region it is estimated that 55% of the TB patients is co-infected with HIV. Mortality is high. The concurrent treatment of TB and HIV is complex especially in low-income countries where the scarce resources make the follow-up of these patients difficult. The Kibongoto National TB Hospital (KNTH) treats TB patients who need admission from the three Northern regions in Tanzania. In KNTH there is very limited experience with the concurrent treatment of TB and HIV. The cornerstone of TB treatment is rifampin. Rifampin has many interactions with other drugs, such as with most of the antiretroviral drugs (ARVs). Many African countries and also the national guidelines for the treatment of HIV advise to give an antiretroviral regimen containing efavirenz (EFV), zidovudine (AZT) and lamuvidine (3TC) when concurrent treatment in TB patients is needed. This regimen has proven to be effective. It is normally well tolerated, but can have side-effects (anemia, CNS effects) so that the treatment needs to be stopped. It is given twice daily with a total of 5 tablets. In addition, the emergence of resistance against efavirenz in the class of the Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) is common. The aim of the present project is to perform phase IIA safety and interaction studies whereby TB and HIV is concurrently treated and whereby it is expected that the antiretroviral drug combinations give little interaction with the standard TB medication and toxicity profiles are favorable. At first, the combination of antiretroviral drugs (efavirenz, tenofovir and emtricitabine, ETE) will be studied. This combination can be given once daily and is expected to have limited side-effects and interactions. Thereafter an alternative regimen with another class of ARVs (the Protease Inhibitors or PIs) are investigated. This project will contribute significantly to capacity building in KCMC and the Kibongoto Hospital in several disciplines. Presently, there is little research capacity in the field of TB in KCMC and KNTH. The research staff will be trained in Good Clinical Practice in the National TB Reference Hospital Dekkerswald in the Netherlands and in RCT in training courses. The KNTH medical and nursing have no experience in the concurrent treatment of TB and HIV. These trials will bring that experience. The laboratory staff in KCMC/KCTC will be trained in more advanced but feasible techniques within the setting of the KCTC. These techniques include assessment of viral load and CD4 positive T cells, sputum culture for TB, and pharmacological analyses with thin layer chromatography and ultraviolet absorption. These skills will be taught integrated in other APRIORI projects. Finally, the laboratory of KNTH, which is presently rudimentary, will be upgraded according to the standards of good laboratory practice for basic diagnostic tests for the follow-up of the TB patients. At the end the Kilimanjaro Region will be provided with an up-to-date protocol for the management of concurrent treatment of TB and HIV. These protocols will be widely communicated with national and international authorities for possible extension.
Related organisations
bullet Secretariat Universitair Medisch Centrum St Radboud (RU)
bullet Financier Nederlandse Organisatie voor Wetenschappelijk Onderzoek - NWO (NWO)
Related people
bullet Project leader Dr. A.J.A.M. van der Ven
Classification
bullet A34800 Drugs and pesticides
bullet A73000 Primary health care and second-line health care
bullet A76000 Patients care
bullet A84200 Education
bullet C20000 Development studies
bullet D21800 Immunology, serology
bullet D23110 Infections, parasitology
bullet D23340 Biopharmacology, toxicology
bullet D24000 Health sciences
Data Supplier: Nederlandse Organisatie voor Wetenschappelijk Onderzoek - NWO
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