High Dose Rifapentine Pharmacokinetics, Tolerability and Safety Dosage Rifapentine for Treatment of Tuberculosis (TBTC-29PK)

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed

Phase 2

Conditions

Smear Positive, Pan-sensitive, Pulmonary Tuberculosis

Treatments

Drug: Rifapentine

Drug: Rifampin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01043575

TBTC Study 29PK

Details and patient eligibility

About

The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.

Full description

This is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in Tuberculosis Trials Consortium (TBTC) Study 29. This PK substudy will use a convenience sample, i.e. be restricted to TBTC sites having logistical capacity for intensive pharmacokinetic sampling. These sites will have non-random selection of patients. In addition to the intensive sampling of 60 patients in this PK study, all patients receiving rifapentine in Study 29 will be eligible for sparse PK sampling as part of the parent treatment protocol.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any patient enrolled in TBTC Study 29.
Provision of informed consent for the study.
Willingness to be sampled in an out-patient clinic or be admitted to a General Clinical Research Center (GCRC) or hospital on one occasion

Exclusion criteria

• Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).