Continuation of HIV Clinical Trial
SAN RAFAEL, Calif., Nov 13, 2000 /PRNewswire via COMTEX/ -- The Clinical Trial
using REMUNE(TM) as a treatment for HIV in Thailand has been approved for an
additional two years. The Study, known as Protocol 2101B, will become one of the
longest scientific examinations of Immune Based Therapy (IBT) for humans
infected with HIV. The approval by two national committees of the Thai
government was made with supporting requests from the attending physicians and
patients for continued access to REMUNE. With these approvals, patients in the
study can continue to receive REMUNE treatment. Results of the study
continuation are not required by the Thai FDA in their consideration of REMUNE
for commercialization.
"We are encouraged by the support and desire by the study participants and
attending physicians to continue to have access to REMUNE in their battle
against HIV. Many patients are now well into their third year of treatment. We
will be getting highly detailed and long-term results of this study, of up to
five years of REMUNE treatment, for future analysis," says Dr. Vina
Churdboonchart, who is principal investigator for the study.
REMUNE is the leading IBT product in human clinical studies around the world for
the treatment of HIV. IBT relies upon the infected individual's own immune
system to ward off progression of the disease as opposed to conventional drug
therapy which may have adverse side effects and may become less effective due to
viral mutation. REMUNE is a result of the scientific collaboration between the
late Dr. Jonas Salk, the renowned creator of the world's first Polio vaccine,
and The Immune Response Corporation which licenses and manufactures REMUNE.
The Clinical Trial originally enrolled 297 volunteers from five university
hospitals (33 volunteers in each of the 9 cohorts), with dosing at 2:1 ratio
REMUNE to placebo (control group). The study results at 40 weeks were the
subject of five presentations at scientific conferences and a publication in the
September 2000 issue of the Journal "Clinical and Diagnostic Laboratory
Immunology". After 40 weeks, all patients received REMUNE. To date,
approximately 88% of the study group remain on treatment using REMUNE, almost
all of whom are not taking any additional anti-viral drugs. A subset of the
study group will receive supplemental treatment using additional therapies after
Week 148. Some study participants have now surpassed 160 weeks of treatment
using REMUNE as the sole therapy.
The study extension was approved by two national committees of the Thai
government, The Technical Subcommittee on AIDS Vaccine Development and the
National Ethical Committee, Ministry of Public Health.
The Immune Response Corporation has agreed to continue to supply REMUNE for this
study. Trinity Medical Group USA will also continue to financially and
administratively support this continuing study. |
