CTN 281: EPIC 4 Study
Effectiveness of early treatment with anti-retroviral therapy in children with HIV
About the Study
This study aims to determine whether early use of combination anti-retroviral therapy (cART) in vertically transmitted cases (HIV passed on from mother to child) results in a state of HIV suppression (very low levels of HIV in the body) that can be controlled without further drug use. This research could pave the way for a potential HIV cure in children.
Background
Vertical transmission (VT) remains a significant source of new HIV cases. In 2012, 260,000 children became infected with HIV in this manner, including an estimated 230,000 in Sub-Saharan Africa alone. Although prevention of VT has been very successful, treatment of vertically transmitted HIV remains difficult.
Recent studies and cases, like the Mississippi baby, suggest that aggressive, early cART treatment in infants can result in sustained HIV suppression, and possibly even HIV remission. It is believed that early initiation of cART can prevent HIV from establishing a significant viral reservoir, which can in turn lead to a state of HIV suppression that can be controlled without drugs.
Study Approach
The research team will assemble a cohort of infants and children who were infected with HIV-1 via VT and started on various cART regimens at different times after birth and who, as a result, achieved HIV suppression. Comparison groups will include children on treatment who have not achieved sustained viral suppression and children who have never been on treatment.
The research team will draw blood samples and measure the size of HIV viral reservoirs in these children at various times and in various cell subsets. They will also assess the presence and levels of other markers of HIV. Results from these experiments will be compared among HIV-infected children who were started early versus late on cART.
If you would like more information on this clinical study, please refer to a participating site or visit the website: https://www.epic4.ca
Eligibility Requirements
Required
- Confirmed HIV-1 infection according to standard diagnostic criteria: (a) detection of HIV-1 DNA by virologic assay in two separately timed blood samples at any age; or (b) confirmatory testing by ELISA and Western blot at 18 months of age or older
- Perinatally-acquired HIV-1 infection
- Voluntary informed consent from patient or from parent/guardian with assent from child where appropriate
Required
- HIV-2 infection
- HIV-1 infection by a route other than perinatal (confirmed or probable)
- Unable to obtain informed consent
Investigators
Here’s who is leading this study.
Can’t find what you’re looking for?
Email ctninfo@ctnplus.ca.
Participating Sites
CHU Sainte-Justine
- Dr. Hugo Soudeyns
- Montréal, QC
McGill University Health Centre – Glen Site
- Dr. Christos Karatzios
- Montréal, QC
CHU Sainte-Justine
- Dr. Fatima Kakkar
- Montréal, QC
CHU Sainte-Justine
- Dr. Norman Lapointe
- Montréal, QC
McGill University Health Centre – Glen Site
- Dr. Dorothy Moore
- Montréal, QC
The Hospital for Sick Children
- Dr. Ari Bitnun
- Toronto, ON
Children’s Hospital of Eastern Ontario
- Dr. Jason Brophy
- Ottawa, ON
The Hospital for Sick Children
- Dr. Stanley Read
- Toronto, ON
CHU Sainte-Justine
- Dr. Valérie Lamarre
- Montréal, QC
Children’s Hospital of Eastern Ontario
- Dr. Lindy Samson
- Ottawa, ON
Hamilton Health Sciences
- Dr. Sandra Seigel
- Hamilton, ON
BC Women’s Hospital and Health Centre of BC
- Dr. Ariane Alimenti
- Vancouver, BC
Stollery Children’s Hospital
- Dr. Wendy Vaudry
- Edmonton, AB
Health Sciences Centre, Children’s Hospital
- Dr. Jared Bullard
- Winnipeg, MB
Health Sciences Centre, Children’s Hospital
- Dr. Joanne Embree
- Winnipeg, MB
Royal University Hospital
- Dr. Ben Tan
- Saskatoon, SK
- Site Investigator
-
12345 Street Name,
City Name, BC V3M 9J3
- Contact Person
- contact@email.com
- 1 (604) 555-9999
- Site Investigator
-
12345 Street Name,
City Name, BC V3M 9J3
- Contact Person
- contact@email.com
- 1 (604) 555-9999
- Site Investigator
-
12345 Street Name,
City Name, BC V3M 9J3
- Contact Person
- contact@email.com
- 1 (604) 555-9999