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CTN 281: EPIC 4 Study

Effectiveness of early treatment with anti-retroviral therapy in children with HIV

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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.

About the Condition

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.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Inclusion Criteria

  • 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.

Exclusion Criteria

  • HIV-2 infection.
  • HIV-1 infection by a route other than perinatal (confirmed or probable).
  • Unable to obtain informed consent.

Sites

Quebec
Dr. Hugo Soudeyns
CHU Sainte-Justine, Montreal
Ph: 514-345-4836

Dr. Christos Karatzios
McGill University Health Centre – Glen Site, Montreal

Dr. Fatima Kakkar
CHU Sainte-Justine, Montreal

Dr. Norman Lapointe
CHU Sainte-Justine, Montreal

Dr. Valérie Lamarre
CHU Sainte-Justine, Montreal

Dr. Dorothy Moore
McGill University Health Centre – Glen Site, Montreal

Ontario
Dr. Ari Bitnun
The Hospital for Sick Children, Toronto

Dr. Jason Brophy
Children’s Hospital of Eastern Ontario, Ottawa

Dr. Stanley Read
The Hospital for Sick Children, Toronto

Dr. Lindy Samson
Children’s Hospital of Eastern Ontario, Ottawa

Dr. Sandra Seigel
Hamilton Health Sciences, Hamilton

British Columbia
Dr. Ariane Alimenti
BC Women’s Hospital and Health Centre of BC (C &W), Vancouver

Dr. Laura Sauvé
BC Women’s Hospital and Health Centre of BC (C &W), Vancouver

Alberta
Dr. Wendy Vaudry
Stollery Children’s Hospital, Edmonton

Manitoba
Dr. Jared Bullard
Health Sciences Centre, Children’s Hospital, Winnipeg

Dr. Joanne Embree
Health Sciences Centre, Children’s Hospital, Winnipeg

Saskatchewan
Dr. Ben Tan
Royal University Hospital, Saskatoon

Additional Information

If you would like more information on this clinical study, please refer to a participating site or visit the website: http://www.epic4.ca

Principal Investigator

Dr. Hugo Soudeyns
CHU Sainte-Justine
Ph: 514-345-4836

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