|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
PACTR201105000291300 |
|
Date of registration:
|
26/04/2011 |
|
Primary sponsor: |
|
|
Public title:
|
A randomised controlled trial of 3 strategies for the treatment of ARV naive HIV infected patients with tuberculosis
|
|
Scientific title:
|
A randomised controlled trial of 3 strategies for the treatment of ARV naive HIV infected patients with tuberculosis |
|
Date of first enrolment:
|
2011-05-27 |
|
Target sample size:
|
1125 |
|
Recruitment status: |
Open to recruitment: actively recruiting participa |
|
URL:
|
HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201105000291300 |
|
Study type:
|
interventional |
|
Study design:
|
Parallel: different groups receive different interventions at same time during study,
Randomised,
Permuted block randomisation (3,6,9),
sealed opaque envelopes,
|
|
|
Countries of recruitment
|
|
South Africa
| | | | | | | |
|
Contacts
|
|
Name:
|
Corinne
Merle |
|
Address:
|
London School of Hygiene & Tropical Medicine
WC1E 7HT
London
United Kingdom |
|
Telephone:
|
+44 2079 272826 |
|
Email:
|
corinne.merle@lshtm.ac.uk |
|
Affiliation:
|
Department of Epidemiology and Infectious Diseases |
|
|
Name:
|
Corinne
Merle |
|
Address:
|
London School of Hygiene & Tropical Medicine
WC1E 7HT
London
United Kingdom |
|
Telephone:
|
+44 2079 272826 |
|
Email:
|
corinne.merle@lshtm.ac.uk |
|
Affiliation:
|
Department of Epidemiology and Infectious Diseases |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Main inclusion criteria:
o Male or female aged 18 or over
o ARV na?ve patients HIV + with CD4 cells more than 50 and less than 350 cells/mm3
o All types of TB disease with bacteriological confirmation
o Written informed consent
Exclusion criteria: Main exclusion criteria:
o Pregnant women or lactating women or women who are unwilling to use contraception
o HIV-2 infected patients
Age minimum:
18 Year
Age maximum:
100 Year
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
HIV/AIDS
Tuberculosis
null
|
|
Primary Outcome(s)
|
|
Mortality from all causes
|
|
Secondary Outcome(s)
|
|
Mortality from all causes
|
|
Percentage of TB relapse and TB recurrence
|
|
Plasma concentrations of rifampicin, isoniazid, pyrazinamide and ethambutol
|
|
Type, frequency and severity of Adverse Events (AEs)
|
|
Source(s) of Monetary Support
|
|
Medical Research Council (MRC-UK)
|
|
Tropical Institute of Medicine
|
|
EDCTP
|
|
National TB program of Benin
|
|
National TB program of Senegal
|
|