The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To assess the safety and tolerance of multiple oral doses of Nevirapine (BI-RG-587). To
generate data on the pharmacokinetics and dose proportionality of Nevirapine with multiple
dosing. To characterize the pattern of virological activity in vivo. Improvement in
virological end points will be examined for association with dose and absorption. To
determine whether development of resistance is reflected in return of virological activity
and, if so, when markers reflect this resistance. To determine if improvements of
immunological endpoints are detectable in the number of patients studied. A compound free of
the toxic effects of nucleoside chain terminators such as zidovudine (AZT) may have an
advantage over currently available treatments for HIV infection. Such a compound has further
advantages if it is active against AZT-resistant isolates. Nevirapine (BI-RG-587) has shown
in vitro inhibitory activity against HIV-1 reverse transcriptase (RT). The molecular
mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to
its binding to an RT site distinct from those for the RNA template primer, the
deoxynucleotide triphosphate or the RNase H catalytic site.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)