Adefovir is a nucleoside analog with activity against a broad spectrum of retroviruses and herpes viruses, including important human pathogens such as HIV-1 and HIV-2, HSV-1 and HSV-2, and CMV. Nelfinavir is a selective, nonpeptide inhibitor of HIV protease with significant antiviral activity measured in cell culture and animal models of HIV infection. Phase I/II clinical trials of nelfinavir indicate that nelfinavir adminsitration leads to substantial decreases in plasma concentrations of HIV-1 RNA and increases of CD4-lymphocytes. The purpose of this study is to evaluate novel, multiple drug combinations with adefovir dipivoxil as par tof a triple combination therapy with nelfinavir and reverse transcriptase inhibitors in pediatric clinical use. The safety and tolerability, the antiviral and immunorestorative effects of the two groups will be compared.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR005096-10A1
Application #
6265803
Study Section
Project Start
1999-07-19
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
10
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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