HIV AIDS News [International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

Protocol 035: Two-Year Data in JAMA
Protocol 035 studied CRIXIVAN in combination with zidovudine (AZT) and
lamivudine (3TC). Fifty-two week data from the study were published in the New
England Journal of Medicine in September 1997. The new JAMA paper reports
the results of a total of 100 weeks of therapy, during which CRIXIVAN continued
to suppress the HIV virus in about 80 percent of patients.
After two years of treatment, about 80 percent of patients had
undetectable levels of HIV (viral RNA less than 500 copies/ml), and a new highly
sensitive assay showed that 60 percent had even lower levels of virus in their
blood (less than 50 copies/ml). Continued viral suppression was accompanied
by a continuing rise in CD4 counts.
"This study has the longest follow-up of any study of a combination
antiretroviral therapy that has resulted in sustained reduction in the amount of
HIV in the blood," said Roy Gulick, M.D., a co-author of the paper who is
Assistant Professor of Medicine, Cornell University Medical College, and
Medical Director, Chelsea Center, The Cornell Clinical Trials Unit. "Protocol 035
is important because it shows that it is possible to reduce viral load durably and
effectively using indinavir-based therapies while preserving quality of life, since
the combinations we studied were generally well-tolerated."
Durability and Convenience Promote Compliance
With extensive evidence supporting the durable effects of CRIXIVAN,
researchers at MSD have begun turning their attention to examining ways to
improve the dosing convenience of CRIXIVAN. Physicians believe that the
convenience of simpler, easier-to-take dosing regimens may result in better
adherence to long-term antiretroviral therapy, potentially reducing the
opportunity for emergence of drug-resistant strains of HIV.