Overview

This trial is active, not recruiting.

Condition recurrent tuberculosis
Treatment moxifloxacin
Phase phase 1/phase 2
Sponsor Centre for the AIDS Programme of Research in South Africa
Start date November 2013
End date December 2016
Trial size 330 participants
Trial identifier NCT02114684, CAP 011

Summary

This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB. The primary objective is to determine if a moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the duration of TB treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol, daily for 24 weeks, see information below. Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks RH(150,75mg), Z (500mg), M (400mg) Dosage and number of tablets dispensed is dependent on participants weight band.
moxifloxacin AVELON
[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)]
(Active Comparator)
An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), daily for 24 weeks duration, substituting Ethambutol for Moxifloxacin. Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks.See details below. (150,75,400,275 mg) RHZE Dosage and number of tablets dispensed is dependent on participants weight band.
moxifloxacin AVELON
[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)]

Primary Outcomes

Measure
A moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, is superior to a control regimen in improving treatment outcomes
time frame: Up to 2 years

Secondary Outcomes

Measure
1.Time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen using data from 2-, 4-, 6-, and 8-week cultures
time frame: Up to 2 years
Compare the proportion of patients with any Grade 3 or 4 adverse reactions
time frame: Up to 2 years
Compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients
time frame: Up to 2 years
Compare the rates of treatment failure and recurrence of the intervention and control arm.
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults ≥ 18 years of age - Previous history of anti-TB chemotherapy - HIV status: HIV infected and uninfected patients are allowed in the study: - All patients must agree to HIV testing to confirm HIV status. - Patients already on ARVs will be allowed in the study provided that the ART regimen is not contraindicated with any of the study agents . - HIV infected patients at any CD4 count irrespective of ART commencement and duration will be included in the study - Smear positive or Gene Xpert positive pulmonary tuberculosis - Rifampicin susceptible as determined by Gene Xpert at screening. Gene Xpert will be used to determine rifampicin resistance, hence the study team will made aware of resistance within 48 hours and prior to study enrolment. - Karnofsky score greater than 70 - Female candidates of reproductive potential must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an Intrauterine Device (IUD), or hormone-based contraceptive) - A negative pregnancy test - Laboratory parameters done at, or 14 days prior to, screening: - Haemoglobin level of at least 7.0 g/dL - Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal - Serum total bilirubin level less than 2.5 times upper limit of normal - Creatinine clearance (CrCl) level greater than 60 mls/min - Platelet count of at least 50 x109cells/L - Serum potassium greater than 3.0 mmol/L Exclusion Criteria: - Patients on a Nevirapine (NVP)-containing ART regimen at screening - Pregnant or breastfeeding - Received an antibiotic active against M. tuberculosis in the last 14 days (e.g. fluoroquinolones, macrolides, standard anti-tuberculosis drugs). - Patients with known M. tuberculosis resistance to any of the study drugs at screening - History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment. - Known allergies or intolerance to any of the study drugs.

Additional Information

Official title An Open Label Randomized Controlled Clinical Trial Comparing a 24Week Oral Regimen Containing Moxifloxacin With a 24 Week Standard Drug Regimen for the Treatment of Smear-positive Pulmonary Tuberculosis in Patients Previously Treated for TB
Principal investigator Nesri Padayatchi, MBChB, MSc
Description Intervention Arm :12 months (6 months treatment + 6 months post treatment follow up) Control Arm :12 months (8 months treatment + 6 months post treatment follow up) Total sample size is 330.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Centre for the AIDS Programme of Research in South Africa.