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ATLANTA -- The AIDS Research Consortium of Atlanta, Inc. (ARCA) announces that it has opened enrollment for "RESIST" Phase III studies of tipranavir, an experimental anti-HIV drug that fights strains of HIV that other currently available drugs cannot. Tipranavir provides hope to patients who have developed drug resistance and therefore have limited treatment options.
"Currently available anti-HIV drugs have enabled people with HIV to live longer, but with long-term treatment, HIV frequently develops resistance to these drugs. Therefore, building effective treatment regimens can often hinge on new anti-HIV drugs coming to market," said Melanie Thompson, MD, founder and principal investigator of ARCA and investigator in the RESIST trial. "We feel that it is important to participate in the RESIST trial in order to help bring new options to patients in Atlanta."
A recent large-scale study in the U.S. estimated that 78 percent of people with HIV have drug-resistant virus.1 Drug resistance develops most commonly when patients do not consistently take their anti-HIV medications. Resistance is a problem because it renders drugs less effective, or even ineffective, and therefore significantly limits treatment options for people with HIV.
The tipranavir Phase III studies are part of the RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir) clinical trial program, the largest study program ever undertaken for HIV-positive patients previously treated with three classes of anti-HIV drugs. RESIST investigators will evaluate the efficacy and safety of tipranavir in more than 280 clinical trial sites worldwide, approximately 100 of which are in the U.S.
Tipranavir is the first of a new generation of anti-HIV drugs called "non-peptidic protease inhibitors" (NPPIs) and is being developed by Boehringer Ingelheim for the treatment of HIV-1 infection in combination therapy. Based on available clinical and in vitro data, tipranavir is active against strains of HIV-1 that are resistant to currently available peptidic protease inhibitors.
The AIDS Research Consortium of Atlanta is a non-profit 501(c)(3) clinical research, treatment, outreach, and education organization founded in 1988. ARCA works through a network of 53 physicians and 6 public health clinics to conduct clinical drug trials, epidemiology studies, patient and care-provider educational programs and outreach programs to various Atlanta communities. Through ARCA, Atlanta residents have access to the latest HIV/AIDS medications through clinical drug trials, usually at no cost to them. ARCA is one of the most respected and successful HIV/AIDS research facilities in the country. Government agencies, corporations, foundations and personal donations support the $1,800,000 annual budget.
-- ARCA has enrolled more than 2,000 metro Atlanta patients in over 150
clinical trials. Our trials have contributed to the licensing by the
FDA of 19 HIV/AIDS therapies that have contributed to the first ever
decline in AIDS death rates since the beginning of the epidemic.
-- ARCA is the largest site in the Adult Spectrum of Disease Study
sponsored by the Centers for Disease Control and Prevention. ARCA has
enrolled over 10,000 patients in this observational study, which
documents change in the disease over time.
-- ARCA was the only research center in Georgia participating in the
first ever, large scale HIV vaccine effectiveness trial.
-- ARCA created the Metro Atlanta Women of Color Initiative (MAWOCI) to
take free HIV rapid testing, prevention education and linkage of care
directly to women in the Atlanta region who face multiple barriers to
traditional healthcare services.
-- ARCA was honored by the Human Rights Campaign with the Dan Bradley
Award for outstanding humanitarian efforts and its work to reach out
to all communities.
1 Richman DD et al. The prevalence of antiretroviral drug resistance in
the US. Program and abstracts of the 41st Interscience Conference on
Antimicrobial Agents and Chemotherapy; December 16-19, 2001; Chicago,
Illinois. Abstract LB-17.
Source: AIDS Research Consortium of Atlanta, Inc.