Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the
safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who
have failed to respond to conventional antiretroviral (HAART) therapy and for whom no
alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is
the management of virologic failure and metabolic complications of anti-HIV treatment.
Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug
potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance
remains the single most important reason for virological failure and rapidly limits treatment
options.