Minimal essential monitoring of HIV-patients in Bangladesh
Lars Henning, PhD, Swiss Tropical Institute, Socinstr. 57, CH-Basel, Switzerland,  Email: lars.henning@unibas.ch

This international clinical research collaboration consists of the International Centre for Diarrhoeal Disease Research, Bangladesh, InPheno, Swiss National Centre for Retroviruses and Swiss Tropical Institute. It aims at improving the care, support and treatment of People living with HIV/AIDS (PLWHA) in Bangladesh by introducing minimal essential monitoring and analyzing the prevailing primary and secondary HIV-resistance genotypically and phenotypically. In the first year we assessed the situation and the needs of the national and international NGOs and governmental bodies which provide care, support and treatment to PLWHA in Bangladesh. Through our collaborative NGOs we have access to approximately 380 HIV-infected patients of approximately 800 known HIV-infected people. A baseline survey revealed that about 160 (45%) of these ~ 380 HIV-positive patients have never had their CD4-T cell counts measured. 89 adult patients are already on antiretroviral treatment but out of these, nine showed clinical features of drug resistance and ten patients had severe side effects when receiving first line treatment. There is one case of laboratory proven intermediate drug resistance signifying that over 20% of the patients do not get adequate treatment by the first line treatment. There are 24 children who are HIV-positive and nine (37,5%) currently need treatment but no pediatric formulation of ARVs is available in Bangladesh. Based on these data (treated as baseline) we plan to develop a clinical data base for all known HIV-patients in Bangladesh who attend a NGO regularly. This will be done in collaboration with the Swiss Red Cross. A Bangladeshi laboratory technician was trained in Switzerland for 6 weeks as part of a technology transfer effort concerning the p24-antigen Elisa.

Because of funding constraints we are started recruitment of 60 patients to carry out a feasibility study to:
1) Establish and validate HIV-p24 as inexpensive yet reliable new marker for HIV disease progression and success of antiretroviral treatment in Bangladesh and test the hypothesis that HIV-p24 can replace viral RNA load as a marker for disease progression and treatment guidelines in areas with limited resources.
2) Introduce primary and secondary genotypic and phenotypic resistance monitoring of HIV to Bangladesh in order to assess the prevalence of primary and secondary drug insensitivity of HIV in Bangladesh and describe the most common resistance conferring mutations in drug-naïve and drug treated HIV-patient.

We plan to move from this pilot study into an exploratory study with a randomized two arm design in 2007. The proposal will be submitted to the Swiss National Foundation for funding and both studies will lay the foundation for further studies urgently needed and to tackle the HIV-situation in Bangladesh adequately.

Contacts:

Dr. Azim
ICDDR,B
GPO Box 128
Dhaka 1000
Bangladesh
Email: tasnim@icddrb.org

Dr. Klimkait
InPheno AG
Vesalgasse 1
CH-4051 Basel
Switzerland
Email: thomas.klimkait@unibas.ch

Prof. Schübpach
SCNR
Gloriastr. 30
CH-8006 Zürich
Switzerland
Email: jorg.schupbach@access.unizh.ch