NCT00023400

TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	Nelfinavir
DRUG	Rifabutin

Timeline

• Start date: 2000-02-01
• Completion: 2002-02-01
• First posted: 2001-09-10
• Last updated: 2005-09-05

Locations

23 sites across 2 countries: United States, Canada