Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201105000291300 Date of Approval: 26/04/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomised controlled trial of 3 strategies for the treatment of ARV naive HIV infected patients with tuberculosis
Official scientific title A randomised controlled trial of 3 strategies for the treatment of ARV naive HIV infected patients with tuberculosis
Brief summary describing the background and objectives of the trial Tuberculosis (TB) is the leading cause of mortality among people with Human Immunodeficiency Virus (HIV) infection, particularly in sub-Saharan Africa.Our proposed project is a multi-centre, open-label randomised controlled trial whose primary objective is to assess the efficacy of three treatment strategies for HIV-positive TB patients who are ARV-naive and have a CD4 count of ¿50 and ¿350 cells/mm3. It will be conducted in Benin, Senegal and Guinea.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RAFA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2011
Actual trial start date 27/05/2011
Anticipated date of last follow up 02/08/2013
Actual Last follow-up date 21/12/2015
Anticipated target sample size (number of participants) 1125
Actual target sample size (number of participants) 780
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (3,6,9) Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (3,6,9) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard strategy 10 mg/kg of Rifampicin Standard duration depending of TB disease Delayed ARV treatment (week 8 after starting TB treatment) combined with standard TB treatment 375
Experimental Group Early ARV 10 mg/kg of Rifampicin Standard duration depending of TB disease Early ARV initiation (week 2) with a standard TB treatment, 375
Experimental Group High dose Rifampicin 15 mg/kg of Rifampicin for 2 months and 10mg/kg for 4 months for 2 months and 4 months or more depending of the type of TB disease Delayed ARV treatment (week 8) with high dose of rifampicin during the intensive phase of TB treatment (15mg/Kg instead of 10 mg/Kg) and standard TB treatment in the continuation phase. 375
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Main inclusion criteria: o Male or female aged 18 or over o ARV naïve patients HIV + with CD4 cells more than 50 o All types of TB disease with bacteriological confirmation o Written informed consent Main exclusion criteria: o Pregnant women or lactating women or women who are unwilling to use contraception o HIV-2 infected patients 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2011 LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2011 National Ethical Committee of Guinea
Ethics Committee Address
Street address City Postal code Country
Ministere de la sante Conakry BP 585 Guinea
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2011 National Ethical Committee of Senegal
Ethics Committee Address
Street address City Postal code Country
Ministere de la sante Dakar Senegal
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2011 National Ethical Committee of Benin
Ethics Committee Address
Street address City Postal code Country
faculte des sciences Cotonou Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality from all causes 12 months after randomisation
Secondary Outcome Mortality from all causes 2 months after randomisation
Secondary Outcome Type, frequency and severity of Adverse Events (AEs) 2 and 12 months after randomisation
Secondary Outcome Percentage of TB relapse and TB recurrence within 12 months after randomisation
Secondary Outcome Plasma concentrations of rifampicin, isoniazid, pyrazinamide and ethambutol After 4 to 8 weeks of TB treatment in the 3 study Arms
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National Hospitalier de Pneumo-Phtisiologie ( CNHPP) Cotonou, Benin Lazaret - Akpakpa Cotonou BP 817 Benin
NATIONAL TB CONTROL PROGRAM rue Aime Cesaire Dakar BP5899 Senegal
SERVICE DE PNEUMO PHTISIOLOGIE Guinee-Conakry CHU Ignace Deen Conakry BP 634 Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
National TB program of Benin Cotonou Benin
EDCTP P.O. Box 93015 2509 AA The Hague 2509 AA Netherlands
Medical Research Council (MRC-UK) United Kingdom
Tropical Institute of Medicine Antwerp Belgium
National TB program of Senegal rue Aimee Cesaire Dakar Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Pr Martin Gninafon Centre National Hospitalier de Pneumo-Phtisiologie Cotonou Benin
Prof. Oumou Bah Sow Service Pneumo-Phtisiologie, CHU Ignace Deen Conakry BP 634 Guinea
Dr Mame Bocar Lo Programme National de Lutte contre la Tuberculose Dakar BP 5899 Senegal
Dr Helen McIlleron University of Cape Town- Division of Clinical Pharmacology Cape Town South Africa
Dr Andre Furco University College London (UCL) London United Kingdom
Dr Tatiana Galperine Service des Maladies infectieuses, Hopital Tenon Paris France
Dr Anandi Martin Institute of Tropical Medicine Antwerp Belgium
Dr Corinne Merle LSHTM London United Kingdom
Dr Boubacar Bah Ignace Deen Conakry Guinea
Dr Alimatou N'Diaye National TB program Dakar Senegal
Dr Dissou Affolabi Centre National Hospitalier de Pneumo-Phtisiologie Cotonou Benin
Sian Floyd LSHTM London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826 London School of Hygiene & Tropical Medicine
City Postal code Country Position/Affiliation
London United Kingdom Department of Epidemiology and Infectious Diseases
Role Name Email Phone Street address
Public Enquiries Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826 London School of Hygiene & Tropical Medicine
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Department of Epidemiology and Infectious Diseases
Role Name Email Phone Street address
Scientific Enquiries Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826 London School of Hygiene & Tropical Medicine
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Department of Epidemiology and Infectious Diseases
REPORTING
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