A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To generate initial information on the pharmacokinetics (blood levels) and dose
proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess
the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children;
and to confirm that the single doses that achieve certain plasma levels in adults achieve
similar levels in HIV-infected children.
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction)
of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus
that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious
adverse effects.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)