The Trinity Medical Group (TMG) was set up in 1995 to sponsor the REMUNE® vaccine clinical trial in Thailand organized by Mahidol University. REMUNE®, a candidate therapeutic vaccine for AIDS, is developed by The Immune Response Corporation (IRC) of San Diego, California, USA
This clinical trial is headed by Principal Investigator, Dr. Vina Churdboonchart, Associate Professor at the Mahidol University.
With approval from the Thailand Ministry of Public Health, the project successfully completed a four-month Safety Test (Protocol 2101A) which involved 30 volunteers from the Ramathibodi Hospital, Bangkok. Volunteers from this study were followed for one year. Results of this study were published in two leading medical journals: Vaccine Vol. 16, No. 3, pp. 142-149 and AIDS 1998, 12: 1521-1527.
REMUNE® was further tested in a Phase II, double-blind, randomized, adjuvant-controlled study (Protocol 2101B) involving 297 volunteers (9 cohorts with 33 volunteers each) to further investigate the therapeutic potential of REMUNE® as an immune-based mono therapy. The study was completed in August 1999.
Results of this study was published in the journal Clinical and Diagnostic Laboratory Immunology, Vol. 7, No. 5, September 2000.
After unblinding at Week 40, this study continued with the Extended Phase II (first phase) from Week 48 to Week 132 which was approved on May 8, 1997. Open-label dosing of Remune was continued for all subjects every 12 weeks. Study result was published in the journal HIV Clinical Trials 2001; 2(5); 391-398. (see Trinity Assets webpage for details)
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