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.: PACTR201304000511413 Date of Registration: 26/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prednisone with early ART in HIV-TB
Official scientific title Preventing Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome in high-risk patients: a randomised placebo-controlled trial of prednisone
Brief summary describing the background and objectives of the trial To determine whether the addition of prednisone to the first 4 weeks of antiretroviral therapy (ART) reduces the risk of paradoxical TB-IRIS in HIV-infected patients being treated for TB who are at high risk of developing TB-IRIS (CD4 <100 cells/¿l) and starting ART within 30 days of TB treatment).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Pred ART Trial
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 Prevention
Anticipated trial start date 01/07/2013
Actual trial start date 28/08/2013
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
Recruitment status Closed to recruitment,follow-up continuing
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 The randomization sequence for the trial will be generated by an independent statistician according to a blocked (block size 8), 1:1 randomisation sequence. sealed opaque envelopes and sequential numbers on envelopes. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Prednisone 40 mg daily for 2 weeks, then 20 mg daily for two weeks Started at the same time as ART initiation and continued for 4 weeks 8 tablets of predisone taken daily for two weeks followed by 4 tablets of prednisone taken daily for two weeks 120 Placebo
Control Group Placebo 8 tablets daily for 2 weeks, then 4 tablets daily for 2 weeks 28 days Identical tablets to prednisone, taken at the same dose for the same duration of time 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV infection CD 4 count equal to or less than 100 cells/microlitre ART naieve Confirmed diagnosis of TB On TB treatment for less than 30 days prior to study entry Eligible for ART and consent to start ART within 30 days of starting TB treatment Written informed consent for trial Kaposi's sarcoma Pregnancy Younger than 18 years of age TB Meningitis or tuberculoma at TB diagnosis 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 04/03/2013 University of Cape Town human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Cape Town, Human Research Ethics Committee, Room 23, Floor E52, Old Main Building, Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No University of Cape Town human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The development of paradoxical TB-IRIS within 12 weeks of starting ART (defined using the International Network for the Study of HIV-associated IRIS (INSHI) consensus case definition Within 12 weeks of study entry.
Secondary Outcome Time to TB-IRIS event From start of ART to onset of IRIS symptoms in days
Secondary Outcome Severity of TB-IRIS event Measured during TB-IRIS event and defined by the following: need for hospitalisation for IRIS, C-reactive protein, neurological involvement.
Secondary Outcome Duration of TB-IRIS event From onset of symptoms/signs to resolution of TB-IRIS symptoms and signs
Secondary Outcome Mortality attributed to TB and TB-IRIS Within 12 weeks of study entry
Secondary Outcome All-cause mortality Within 12 weeks of study entry
Secondary Outcome Other (non-TB) IRIS events Within 12 weeks of study entry
Secondary Outcome Quality of life assessment Enrolment Week 4 Week 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ubuntu Clinic, Khayelitsha Site B Site B, Lwandle Road, Khayelitsha Site B, 7784 Cape Town 7784 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP EDCTP Secretariat Cape Town Francie van Zijl Drive, Parowvallei Cape Town, South Africa Cape Town 7503 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town University of Cape Town, Private Bag X3, Rondebosch 7701, South Africa Cape Town 7701 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Gary Maartens Division of Clinical Pharmacology Department of Medicine K45 Old Main Building Groote Schuur Hospital Observatory 7925 South Africa Cape Town 7925 South Africa
Prof Lutgarde Lynen Department of Clinical Sciences Institute of Tropical Medicine Nationalestraat 155 2000 Antwerp Belgium Antwerp 2000 Belgium
Robert J. Wilkinson Institute of Infectious Disease and Molecular Medicine Faculty of Health Sciences University of Cape Town Anzio Road, Observatory, 7925 South Africa Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Graeme Meintjes graemein@mweb.co.za +27 21 4066075 Institute of Infectious Diseases and Molecular Medicine (IIDMM), Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Charlotte Schutz Charlotte.Schutz@uct.ac.za +27 21 4066389 Institute of Infectious Diseases and Molecular Medicine (IIDMM), faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Medical Officer
Role Name Email Phone Street address
Scientific Enquiries Graeme Meintjes graemein@mweb.co.za +27 21 4066075 Institute of Infectious Diseases and Molecular Medicine (IIDMM), Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Scientific Enquiries
REPORTING
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