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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: www.pactr.org

Trial no.: PACTR201105000291300 Date registered: 2011/04/26
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 HIV/AIDS , Tuberculosis ,
Purpose of the trial Treatment
Anticipated trial start date 2011-05-02
Actual trial start date 2011-05-27
Anticipated date of last follow up 2013-08-02
Actual date of last follow up
Anticipated target sample size (number of participants) 1125   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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)

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 Min age Max age Gender
Main inclusion criteria: o Male or female aged 18 or over o ARV naïve 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 Main exclusion criteria: o Pregnant women or lactating women or women who are unwilling to use contraception o HIV-2 infected patients 18 Years 100 Years 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 2011/03/17 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 2011/02/24 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 2011/03/15 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 2011/03/18 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 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
Secondary Outcome Mortality from all causes 2 months after randomisation

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SERVICE DE PNEUMO PHTISIOLOGIE Guinee-Conakry CHU Ignace Deen Conakry BP 634 Guinea
NATIONAL TB CONTROL PROGRAM rue Aime Cesaire Dakar BP5899 Senegal
Centre National Hospitalier de Pneumo-Phtisiologie ( CNHPP) Cotonou, Benin Lazaret - Akpakpa Cotonou BP 817 Benin

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
Tropical Institute of Medicine Antwerp Belgium
Medical Research Council (MRC-UK) United Kingdom
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 Fax
Principal Investigator Dr Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826 +44 207 636 8739
Street address City Postal code Country Position / Affiliation
London School of Hygiene & Tropical Medicine London United Kingdom Department of Epidemiology and Infectious Diseases
Role Name Email Phone Fax
Public Enquiries Dr Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826
Street address City Postal code Country Position / Affiliation
London School of Hygiene & Tropical Medicine London WC1E 7HT United Kingdom Department of Epidemiology and Infectious Diseases
Role Name Email Phone Fax
Scientific Enquiries Dr Corinne Merle corinne.merle@lshtm.ac.uk +44 2079 272826
Street address City Postal code Country Position / Affiliation
London School of Hygiene & Tropical Medicine London WC1E 7HT United Kingdom Department of Epidemiology and Infectious Diseases