Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are insufficient data correlating concentrations of anti-TB drugs with treatment response. We hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with inadequate TB treatment response to Mycobacterium tuberculosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Treatments: Antitubercular Agents; Ethambutol; Isoniazid; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent

• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

• Age of ≥18 years

• First episode of pulmonary TB i.e. proven or highly suspected TB considered for TB treatment qualifying for 6 months anti-Tb drugs regimen

• Confirmed HIV-1 infection

Exclusion Criteria:

• Unable to provide informed consent

• Documented or highly suspected TB infection of any organs/systems other than the lung requiring TB treatment longer than 6 months

• Previously treated for a mycobacterial infection (TB or atypical mycobacterial infection, active or latent)

• Pregnancy or planned pregnancy within the next year

• Unwillingness to perform pregnancy test

• Decompensated liver disease and/or aminotransferases >5x ULN

• GFR < 50 ml/min

• Co-morbidities reducing life expectancy to <1 year (e.g. cancer)

• Patient wishes to take part in another interventional study