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.: PACTR201810587719948 Date of Approval: 31/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Low frequent HIV drug resistant polymorphisms in infants born to HIV sero-positive mothers: Implications on response to therapy
Official scientific title Low frequent HIV drug resistant polymorphisms in infants born to HIV sero-positive mothers: Implications on response to therapy
Brief summary describing the background and objectives of the trial Abstract In the present era where the major focus is on eliminating mother to child transmission of HIV, so much has been done to attain the now evidenced results. This has been more pronounced in the developed world where access to care and availability of resources have driven the mother to child transmission rates of HIV to levels as low as <1%. In the developing world however, lack of accessibility to care plus, lack of resources is causing these rates to lag behind. It is undeniable that even in the developing countries efforts have been made but there is still a lot that needs to be done. In this document, we propose to focus on one of the most vulnerable groups: HIV sero-positive infants born to HIV sero-positive mothers. With the elimination of mother to child transmission of HIV program, it is crucial that the infants who sero-convert get the best care to enable them live a productive life. In the low resource settings, these infants are initiated on a regimen without prior assessment of presence of drug resistance mutations. We propose to use cutting edge technology (Next generation sequencing) to determine the prevalence of drug resistance mutations (even at the lowest level) in these infants and also follow up these infants to see what impact these low level mutations have on response to therapy (in a longitudinal three year study using dry blood spot samples). Findings from this study will pave way for future recommendations in the standard of care guidelines at the national level as well as at
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DRIBS
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 01/09/2017
Actual trial start date 01/07/2018
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 260
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Baseline HIV Drug resistance testing at baseline in the intervention at baseline then for all patients with a viral load greater than 1000 copies/ml Prior to initiation of ART, a baseline drug resistance test is performed in HIV positive babies right after a positive Early infant diagnosis result. Treatment is then given based on the HIV drug resistance profile. The babies are then followed up with viral loads being done every six months for a period o two years. 130
Control Group No baseline line drug resistance testing babies are initiated on ART according to the Ministry of Health guidelines. they are then monitored for two years for virologic suppression by performing a viral load every six months two year monitoring Following a positive HIV Early Infant Diagnosis test, babies are initiated on ART according to the Ministry of Health guidelines. they are then monitored for two years for virologic suppression by performing a viral load every six months. Those that have a viral load greater than 1000 copies/ml, an HIV Drug resistance test is performed using Next Generation sequencing and treatment is changed based on HIV Drug resistance results. 130 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Male or Female infant • Up to six months of age • Confirmed HIV positive test following DNA PCR • Has not been started on any combination antiretroviral therapy • Mother or care taker willing to consent for both her and the child • Involvement in another study for the baby • Presence of any very serious illness • Any other documented medical illnesses that are not well controlled Infant: 0 Month(s)-12 Month(s) 6 Week(s) 6 Month(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 17/01/2018 Joint Clinical Research Center Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
plot 101 Lubowa Estates Kampala 10005 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Detection of a viral load greater than 1000 copies. These patients then based on the regimen they are taking, a drug resistance test will be done and switched to a regimen as dictated by the drug resistance results. every six months
Secondary Outcome Determination of levels of adherence in patients with a detectable viral load greater than 1000 copies/ml. every six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Joint Clinical Research Center Plot 101 Lubowa Estates Kampala 10005 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51, 2593 HW The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Joint Clinical Research Center Plot 101 Lubowa estates Kampala 10005 Uganda HIV treatment and research center
COLLABORATORS
Name Street address City Postal code Country
Christine Matama Plot 101 Lubowa estates Kampala 10005 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Immaculate Nankya inankya@jcrc.org.ug +256701974134 plot 101 lubowa estates
City Postal code Country Position/Affiliation
Kampala 10005 Uganda Senior virologist
Role Name Email Phone Street address
Public Enquiries Christine Matama cmatama@jcrc.org.ug +256706445782 plot 101 lubowa estates
City Postal code Country Position/Affiliation
Kampala 10005 Uganda Study coordinator
Role Name Email Phone Street address
Scientific Enquiries Cissy Kityo ckityo@jcrc.org.ug +256417723000 plot 101 lubowa Estates
City Postal code Country Position/Affiliation
Kampala 10005 Uganda Executive Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information