The new compound MKC-442 is an NNRTI which has demonstrated potent in vitro activity against HIV-1 both as a single agent and in combination with other anti-HIV drugs. Data from in vitro studies have demonstrated antiretroviral activity of MKC-442 against various strains of HIV-1, including clinical isolates and strains with reduced sensitivity to ZDV. In the laboratory, combinations of MKC-442 with ddI produced moderate synergy while combination with ddC was additive in inhibiting HIV-1 infection. When used in combination with ZDV or with ZDV and saquinavir, impressive synergistic inhibition of HIV-1 replication was observed. When MKC-442 was combined with ZDV and 3 TC, the drugs synergistically suppressed HIV-1 replication in MT-4 cells over a wide range of doses. Since in vitro evidence indicates that strains of HIV-1 with reduced sensitivity to MKC-442 can emerge upon exposure to MKC-442 as a single agent, MKC-442 would be most effectively used in combination with other agents in the treatment of HIV-1 antiviral agents in the long-term treatment of HIV disease. This protocol aims to study the efficacy, safety, and tolerability of a combination of MKC-442 Viracept in the background of either stavudine (d4T) plus lamivudine (3TC) or stavudine (d4T) plus didanosine (ddI).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-12
Application #
6458599
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
12
Fiscal Year
2001
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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