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.: PACTR201502001028169 Date of Approval: 04/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Aetiology of treatment failure in HIV positive children and adolescents on boosted protease inhibitor based regimens.
Official scientific title Aetiology of treatment failure in HIV positive children and adolescents on boosted protease inhibitor based regimens.
Brief summary describing the background and objectives of the trial The prevalence of treatment failure in patients on boosted protease inhibitor based regimens is high (20-40%) in southern Africa and the contribution of different factors to that failure rate has not been elucidated. Treatment failure has largely been attributed to poor adherence, yet recent evidence has shown that some patients are able to achieve and maintain viral suppression despite sub-optimal adherence. Therefore, there might be other factors contributing to treatment failure, such as sub-optimal drug levels (pharmacological factors), despite adequate adherence, and virological factors (drug resistance), despite the high genetic barrier to resistance of boosted protease inhibitors. To date, there have been no systematic studies to elucidate all the contributors to virological failure in a large paediatric HIV-infected population in Zimbabwe. We seek to study and quantify the cause/s of treatment failure at the Harare central hospital paediatric opportunistic infections (OI) clinic with the aim of ultimately designing interventions to reduce treatment failure rates in this setting and in other settings as well. Research question- What is the cause/s of virological treatment failure in HIV positive children and adolescents on ritonavir boosted atazanavir (ATV/r) based regimens as second line therapy at Harare hospital paediatric OI clinic? Objectives 1. To measure drug exposure of atazanavir in HIV positive children and adolescents on second line treatment using plasma and hair concentrations 2. To determine treatment success in directly administered antiretroviral therapy (DAART) plus standard adherence counselling intervention versus standard adherence counselling and self-administered treatment (SAT) 3. To determine and quantify the causes of non-suppression in patients on ATV/r based regimens: including poor adherence, pharmacokinetic parameters (inadequate plasma drug levels), viral properties (drug resistance) or host factors
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ATF study
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: Drugs
Anticipated trial start date 01/07/2014
Actual trial start date 03/02/2015
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
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
Randomised Simple randomisation by using a randomisation table created by a computer software program. Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Directly administered antiretroviral therapy (DAART) 90 consecutive days Home visits to participants homes by field workers on schedulede days. 65 Active-Treatment of Control Group
Control Group Self administered therapy (SAT) 90 consecutive days 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Parents/guardian willing to consent 2. Child willing to provide assent 3. Documented HIV positive antibody or antigen test 4. Child knows their HIV status 5. Aged between 6 and 16 years (that is, from the day of their sixth birthday up to the eve of their seventeenth birthday) 6. Registered at Harare hospital paediatric opportunistic infections clinic 7. On second line treatment (ATV/r based) 8. Have taken the above named second line treatment for at least 6 complete, consecutive months 9. Has virological and immunological treatment failure as defined by WHO 2012 criteria 1. Patients registered at other health centres who have been referred for specialist care at Harare hospital paediatric opportunistic infections clinic 2. On ATV/r as first line treatment 3. Patients who do not want to be followed up at home. 6 Year(s) 18 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 31/07/2014 Medical Reseach Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Corner Josih Tongogara/ Mazowe street Harare +263 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Virological failure Baseline- at time of entry into study Outcome- at the end of 90 consecutive days from time participant entered study
Secondary Outcome Atazanavir concentration in hair Baseline- at study entry Outcome- 90 days from day of study entry.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Harare Central Hospital P O Box ST 14, Southerton Harare +263 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center Building 31 31 Center Drive, MSC 2220, Bethesda 20892-2220 Bethesda +1 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Zimbabwe P O Box MP167, Mount Pleasent Harare +263 Zimbabwe University
COLLABORATORS
Name Street address City Postal code Country
Prof CFB Nhachi PO Box A195 Harare +263 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tariro Chawana tdchawana@gmail.com +263 773 276 306 PO Box A195, Avondale
City Postal code Country Position/Affiliation
Harare +263 Zimbabwe DPhil student
Role Name Email Phone Street address
Public Enquiries Tariro Chawana tdchawana@gmail.com +263 773 276 306 P O Box A195 Avondale
City Postal code Country Position/Affiliation
Harare +263 Zimbabwe DPhil student
Role Name Email Phone Street address
Scientific Enquiries Tariro Chawana tdchawana@gmail.com +263 773 276 306 P O Box A195 Avondale
City Postal code Country Position/Affiliation
Harare +263 Zimbabwe DPhil student
REPORTING
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