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Ministry begins testing GPO-Vir: Anti-retroviral to be used at 400 hospitals - December 20, 2002 The Public Health Ministry has begun human trials of GPO-Vir, an anti-retroviral cocktail for treating HIV/Aids that was devised by the Government Pharmaceutical Organisation (GPO). Under a programme jointly supported by the government and the Global Aids Fund, some 13,000 HIV/Aids carriers at 400 hospitals nationwide will have their health monitored after being given GPO-Vir. The drug is a combination of the anti-retrovirals Navirapine, Starvudine and Lamivudine, and has been produced by the GPO since April, he said. If the trials proved successful, the GPO planned to manufacture 15 million tablets per year, at a cost of 20 baht per tablet. The ministry was hoping to expand distribution of the drug to 800 hospitals over the next two years under a programme to be jointly carried out with the Mental Health Department, which would provide counselling to patients, Dr Charal said. GPO chief Thongchai Thavichachart said the drug could be given to patients without resistances to drugs for up to seven years, if taken as directed. Deviations from the recommended dosage could reduce the drug's effectiveness to two years, he said. Protocol IB 3102/1 Amendment No. 1, Sept. 02, 2002 PROTOCOL IB3102/1 SUMMARY Title: Studies of Immune-Based Therapy for HIV/AIDS Using HIV-1 Immunogen (REMUNE®) and Antiviral Drugs, GPO-VIR®,in HIV+ Volunteers Study Objectives: 1. To determine the safety and efficacy of Thai Government Pharmaceutical Organization (GPO) antiretroviral drugs, GPO-VIR® and HIV-1 Immunogen with GPO-VIR®, on CD4 cell counts, viral load, adverse events, quality of life and cost-benefit of treatment in HIV-infected volunteers. 2. To determine any drug resistance in the subjects in both treatment arms: (1) GPO-VIR® and (2) Remune® + GPO-VIR® Study Design: 1. Open Label Control Study 3. Concerted effort program to evaluate GPO-VIR® treatment only Arm 1) and HIV-1 Immunogen in combination with GPO-VIR® (Arm 2). Subject Population: 170 HIV-infected subjects with CD4+ cell counts less than 200 cells/ul, categorized into two (2) subgroups, 85 subjects in each subgroup. Inclusion Criteria: HIV-1 seropositive by ELISA and Western Blot; 15 years of age or older; non-pregnant females, non-alcoholic, no chronic illness nor mental illness. The subject must be able and willing to sign an informed consent. Exclusion Criteria: Current treatment for malignancy other than basal cell or squamous cell carcinoma of the skin, non-systemic Kaposi's sarcoma or carcinoma in situ of cervix. Alcoholic, drug addict, pregnancy and imprisonment, chronic illness or mental illness. Study Duration: One year with interim analysis at Week 12 and Week 28. Collaborating Institutes: 1. Khon Kaen University,Department of Medicine, Khon Kaen University Khon Kaen, Thailand,PI: Dr. Wisut Sukeepaisarncharoen 2. Mahidol University, Bangkok, Thailand,PI: Dr. Vina Churdboonchart,Department of Pathobiology, Faculty of Science,Dr. Worachart Sirawaraporn.Department of Science, Faculty of Science Asst. Prof. Chaweewon Boonshuyar,Department of Biostatistics, Faculty of Public Health 3. Ramathibodi Hospital, Bangkok, Thailand,Virology and Molecular Microbiology Unit,Department of Pathology, Faculty of Medicine,Mahidol University PI: Dr. Wasun Chantratita 4. Vajira Hospital, Bangkok Metropolitan Authority Bangkok, Thailand PI: Dr. Sang-a-roon Kulpradist 5. Songklanagarind Hospital,Songklanagarind University,Songkla, Thailand PI: Dr. Verapol Chandeying 6. Nakornpathom Hospital, Ministry of Public Health,Nakornpathom Province, Thailand PI: Dr. Oraphin Kamsao 7. The Immune Response Corporation, Carlsbad, California, USA, Investigators: Dr. Dennis Carlo and Dr. Ronald B. Moss.́
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