Serono SA, of Geneva, reported positive results of two clinical trials of Serostim [somatropin (rDNA origin) for injection] for the treatment of AIDS-related metabolic complications. The presentation was made at the at the XIV International AIDS Conference 2002 in Barcelona, Spain, which continues through Friday. The Serostim study for the treatment of adipose redistribution syndrome was a Phase II/III double-blind, placebo-controlled trial in 239 patients. The co-primary endpoints were a reduction in visceral adipose tissue as assessed by CT scan and the ratio of trunk-to-limb fat as assessed by DXA technology. Results of that study indicated that Serostim has a potential role in the treatment of body composition issues associated with lipodystrophy. A second study, a Phase IV trial for AIDS wasting, confirmed that Serostim was able to restore lean body mass. Serostim is the only growth hormone approved by the FDA for the treatment of AIDS wasting, or cachexia.
The International AIDS Vaccine Initiative outlined a new research and development agenda that it and its worldwide partners are undertaking to expedite the development of vaccines to prevent HIV/AIDS, focusing on those tailored for use in the developing world. The IAVI pledged to accomplish four principal goals, ranging from identifying and addressing the primary challenges still impeding AIDS vaccine development to ensuring that second-generation AIDS vaccines also are accelerated to efficacy testing.
Trimeris Inc., of Durham, N.C., said data collected from two Phase III trials suggested subcutaneous delivery of T-20, a fusion inhibitor, was well accepted by a majority of patients after the first eight weeks of treatment. A separate presentation found that weight-based dosing of T-20 in HIV-infected children and adolescents was well tolerated and provided exposures of T-20 comparable to those seen in adults.
ViroLogic Inc., of South San Francisco, said 11 studies using its PhenoSense drug resistance testing technology will be presented at the conference. The findings of one study demonstrated that combined phenotypic/genotypic testing provides the most comprehensive resistance information to help physicians make HIV treatment decisions. Researchers used the combination assay to simultaneously perform drug resistance tests on about 200 patients, 85 percent of whom had experienced two or more treatment failures. The research team found that phenotypic and genotypic test results differed for 75 percent of the patients studied. The study also found that human antibodies, previously thought to have little influence in controlling the replication of DNA, in fact play an important role in the body's response to the virus.
Visible Genetics Inc., of Toronto, said its studies revealed that 20 percent of recently infected HIV patients in the UK had resistant virus. Deenan Pillay, director of the Public Health Laboratory Service Antiviral Susceptibility Reference Unit in the UK, said that with resistance running at those levels following initial infection, physicians should be moving toward routine resistance testing before initiating therapy.