The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Status:
Completed
Trial end date:
1999-08-01
Target enrollment:
Participant gender:
Summary
To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients
with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir
dipivoxil in preventing the development of CMV end-organ disease in patients with advanced
HIV coinfected with CMV.
The optimal treatment for HIV infection and the prevention of CMV disease has not been
identified. Currently available antiretroviral therapies are hampered by both significant
toxicities and the development of resistance. In addition, agents for preventing CMV disease,
such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance
secondary to toxicities. Moreover, discordant results have been reported regarding the
effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer
agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety
profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug
of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and
herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its
anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the
incidence of opportunistic herpesvirus infections and prolong survival in patients with
advanced HIV infection.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)