Extract

Background and study aims This is a study of adults (both male and female) with human immunodeficiency virus (HIV) infection who become infected with Penicillium marneffei, which causes a deadly infection known as penicilliosis . There are two drugs used to treat this infection in Viet Nam: amphotericin B and Itraconazole. Itraconazole is taken by mouth and is less expensive, while amphotericin B is taken through intravenous infusion, which is less convenient, causes more drug reactions, is more expensive and requires a higher level of care. Current WHO and Vietnamese guidelines recommend amphotericin B as the treatment of choice. Amphotericin B is not available in many resource-limited settings and doctors still use itraconazole to treat this disease. Experience in these settings shows that this treatment is effective. This study is designed to find out if itraconazole works as well as amphotericin B. Who can participate? Participants have to be HIV positive, be over 18 years old and suffer from penicilliosis (identified from blood, skin lesion scrapping, lymph node or bone marrow biopsy). What does the study involve? Participants will randomly be allocated to one of the two treatments: amphotericin B (0.7 mg/kg/day) through a vein in their arm or itraconazole by mouth (600 mg/day for 3 days, then 400 mg/day) for the first 2 weeks. Then everyone will be given itraconazole by mouth (400 mg/day) for the remaining 10 weeks of the treatment. What are the possible benefits and risks of participating? Participants will be treated according to regular clinical care when participating to the study. As we do not know if the drugs work in the same way, participants may not benefit directly from being in the study. The study results will help understanding how to best treat this fungal infection and it may help others with this disease in the future. The risks associated with this study are the same as those which patients will experience in clinical care. Both drugs are routinely used in clinical care and study procedures will follow regular guidelines. A small amount of additional blood will be taken for laboratory tests which are not routine, but may improve diagnosis and understanding of the disease. Where is the study run from? There will be four study sites in Viet Nam: Hospital for Tropical Diseases in Ho Chi Minh City, Bach Mai Hospital, National Hospital for Tropical Diseases in Hanoi, Uong Bi Viet Nam – Sweden Hospital in Quang Ninh Province and Viet Tiep Hospital in Hai Phong Province. When is the study starting and how long is it expected to run for? The study started in October 2012 and should last about four years. Who is funding the study? Funders of this trial are: The Department for International Development, the Wellcome Trust and the Medical Research Council in the UK. Who is the main contact? Dr Thuy Le [email protected]

Inclusion criteria

• Penicillium marneffei

Links

• ictrp
• isrctn