TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
Status:
Completed
Trial end date:
2002-02-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective:
To define the impact of nelfinavir (given at 1250mg bid as part of a combination
antiretroviral regimen) on peak levels and area under the curve for rifabutin and the
rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as
part of tuberculosis chemotherapy.
Secondary Objectives:
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with
twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg
twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of rifabutin and
25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients
with HIV-related tuberculosis.
To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with
HIV-related tuberculosis.
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic
studies.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
US Department of Veterans Affairs VA Office of Research and Development