A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and
preliminary activity of nevirapine administered alone in mildly to moderately symptomatic
HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the
safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to
less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance,
pharmacokinetics, and preliminary activity of nevirapine administered in combination with
zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to
less than 18 years.
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic
than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro
inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition
of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)