Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes (SOUTH)
Recruitment status was: Recruiting
|AIDS With Tuberculosis||Drug: Rifampicin, Isoniazid, Ethambutol, Pyrazinamide||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes in HIV-tuberculosis Co-infected Ugandan Adults|
- clinical outcome [ Time Frame: At the end of treatment (6 months after enrolmet) ]To investigate the association between serum concentrations of antituberculosis drugs and tuberculosis treatment response in HIV-TB-co-infected individuals.
- Cmax [ Time Frame: At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation ]To investigate the steady-state pharmacokinetic parameters of anti-TB drugs at different time-points over the course of TB-treatment
- Number of adverse events [ Time Frame: 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation ]To assess the safety and tolerability of anti-TB drugs based on the WHO guidelines
- ART trough levels [ Time Frame: At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation ]To correlate the effect of anti-TB drugs on plasma concentrations of efavirenz or protease inhibitors and vice versa.
- Isoniazid Cmax [ Time Frame: At 2 weeks, 8 weeks and 24 weeks ]To evaluate the effect of acetylator geno-and phenotype (NAT-2 gene) on isoniazid plasma concentrations and toxicity
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Rifampicin, Isoniazid, Ethambutol, Pyrazinamide tablets 3 to 5 tablets once daily for 2 months followed by Rifampicin, Isoniazid 3 to 5 tablets once daily for 4 months
Drug: Rifampicin, Isoniazid, Ethambutol, Pyrazinamide
Rifampicin, Isoniazid, Ethambutol, Pyrazinamide: 3, 4 or 5 tablets daily for weight below 55kg, above 55kg or above 70kg respectively for first 2 months followed by Rifampicin, Isoniazid: 3, 4 or 5 tablets daily for patients' weight below 55kg, above 55kg or above 70kg respectively for 4 months
During the study periodic monitoring will be conducted to ensure that the protocol and Good Clinical Practices (GCPs) are being followed.The monitors may review source documents to confirm that the data recorded on CRFs is accurate. The study site may be subject to review by the Institutional Review Board (IRB) and/or appropriate regulatory authorities.
A CRF will be completed for each included subject and will be signed by the investigator or by an authorized staff member to attest that the data is true. Any corrections to entries made in the CRFs, source documents must be dated, initialed and explained (if necessary) and should not obscure the original entry. Qualit assurance will as also be performed regularly on the CRFs.
The primary end point will be analyzed using Time to event (cure, death, relapse etc)analysis and failure rates and hazard ratios will be calculated accordig to categorical drug concentrations with proposed cutt offs.
Secondary end points will be analysed using time to event for occurence of toxicities which will also be corelated to the drug concentrations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782950
|Contact: Andrew Kambugu, MMED||+256-414-307000 ext firstname.lastname@example.org|
|Infectious Diseases Institute||Recruiting|
|Kampala, Uganda, 256|
|Contact: Christine Sekaggya, MMed +256312307000 ext 370 email@example.com|
|Principal Investigator: Barbara Castelnuovo, MBChB, PhD|
|Principal Investigator:||Barbara Castelnuovo, MD, PhD||Infectious Diseases Institute|