HIV Infections Clinical Trial
Official title:
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
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.
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.
Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days
after the third patient receives the lower dose, three additional patients receive the
higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure
blood levels of the drug.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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