HIV Infections Clinical Trial
Official title:
An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3)
To assess the safety and tolerance of multiple oral doses of nevirapine in combination with
zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose
proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of
virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine
whether development of resistance to either drug is slowed by the use of the combination.
Drugs now used in treatment for patients with AIDS show some toxicity which limits their
usefulness. In addition, with long-term treatment with AZT, there is evidence of virus
resistance to the drug. Compounds that are more effective and less toxic than those in
present use would be beneficial, especially if they are active against AZT-resistant
viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV
replication (reproduction). In vitro studies have shown that nevirapine and AZT work
together to inhibit HIV replication.
Drugs now used in treatment for patients with AIDS show some toxicity which limits their
usefulness. In addition, with long-term treatment with AZT, there is evidence of virus
resistance to the drug. Compounds that are more effective and less toxic than those in
present use would be beneficial, especially if they are active against AZT-resistant
viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV
replication (reproduction). In vitro studies have shown that nevirapine and AZT work
together to inhibit HIV replication.
Groups of 10 patients are studied at each of three dose levels. Five patients at each dose
level have less than 3 months of prior AZT treatment; five patients at each dose level have
at least 12 months of previous AZT treatment and tolerated an AZT regimen of 600 mg/day (200
mg every 8 hours). At least 24 patient-weeks of treatment with the combination treatment
must be completed without requiring dose interruption before the next dosage level can be
started. All 30 patients must be enrolled at a lower dosage level before a higher dosage
level is started. Patients begin treatment with AZT. 14 days later, patients begin treatment
with nevirapine in addition to the AZT. After 24 weeks, patients have the option to continue
long-term treatment with either nevirapine or standard treatment.
;
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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