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.: PACTR201609001751384 Date of Approval: 23/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Malnutrition and Antiretroviral Timing in Children with HIV (MATCH)
Official scientific title A comparison of early vs. delayed initiation of HAART in severely malnourished HIV-infected children.
Brief summary describing the background and objectives of the trial INTRODUCTION: Malnutrition is a common presenting clinical problem in HIV-infected children in developing countries and is often the initiating event prompting health care seeking behavior. The initiation of HAART in malnourished children has been previously associated with higher mortality (Patton, Sangeetha et al. 2006) and delayed immunological recovery (Bandyopadhyay and Bhattacharyya 2008) compared to non-malnourished children. The reasons for these findings are poorly understood, but may be related to poor absorption of antiretroviral therapy during the acute phase of malnutrition. STUDY OBJECTIVES Primary Objective: 1. To compare the nutritional, immunological, and virological responses to HAART at 48 weeks i Secondary Objectives: 1. To compare the mortality at 48 weeks in HIV infected severely malnourished children started immediately on HAART versus children in whom HAART is delayed until their severe malnutrition is resolved. 2. To determine the pharmacokinetics of common anti-retroviral drugs in severely malnourished children. 3. To describe the incidence and spectrum of adverse events, co-infections and the effect of tuberculosis co-infection in HIV infected severely malnourished children on mortality, immunological and virological responses to HAART.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MATCH
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2012
Actual trial start date 13/07/2012
Anticipated date of last follow up 01/12/2015
Actual Last follow-up date 01/12/2015
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 84
Recruitment status Completed
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 (blocks of 10) Central randomisation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Early Arm Antiretroviral drug initiation within 14 of nutritional rehabilitation 42 Active-Treatment of Control Group
Control Group Delayed Arm Antiretroviral drug initiation after 14 days of nutritional rehabilitation and/or nutritional recovery 42 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 1 months - 12 years 2. HIV infection as defined as a positive ELISA or Rapid HIV test in children over 18 months or a positive DNA PCR in children under 18 months. 3. ART-naïve except for antiretroviral prophylaxis given for PMTCT. 4. Severe acute malnutrition (SAM) as defined by WHO criteria: Weight-for-length 3 z-scores below the WHO growth standards median or Mid-upper arm circumference (MUAC) < 115 mm with/without peripheral edema. 5. Eligible for initiation of HAART by the SA national treatment guidelines 1. Enrollment in other interventional studies. 2. Lack of availability of parent/guardian willing and able to provide informed consent and adhere to study protocol. 1 Month(s) 12 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 27/03/2012 University of KwaZulu Natal Biomedical Research Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Westville Campus Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anthropometric response (BMIZ/WAZ/HAZ) 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Primary Outcome Virological Response (VL<1000c/ml) 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Primary Outcome immunological response 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome mortality 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome adverse events/IRIS events 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
King Edward VIII Hospital Corner of Sydney and Rick Turner Road, Congella Durban 4013 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UKZN Phd Grant 719 Umbilo Road Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr M Archary 719 Umbilo Road, Congella Durban 4001 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Phillip La Russa Department of Pediatrics, College of Physicians & Surgeons, Columbia University , New York, New York, U.S.A New York United States of America
Raziya Bobat 719 Umbilo Road, Congella Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moherndran Archary archary@ukzn.ac.za +27 312604318 719 Umbilo Road, congella
City Postal code Country Position/Affiliation
Durban 4001 South Africa Hon Lecturer/Senior Specialist Paediatric Infectious diseases
Role Name Email Phone Street address
Public Enquiries Moherndran Archary archary@ukzn.ac.za +27312604318 719 Umbilo Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Hon. Lecturer
Role Name Email Phone Street address
Scientific Enquiries Moherndran Archary archary@ukzn.ac.za +27312604318 719 Umbilo Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa hon. Lecturer
REPORTING
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