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CTN 254: Inflammation as a predictor of HIV disease progression

Predictive value of inflammatory biomarkers in untreated HIV disease progression, and their response to initiation of antiretroviral therapy

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About the study

The aim of this study is to determine whether inflammatory markers (molecules that detect inflammation) can predict HIV disease progression in persons who have not started highly active antiretroviral therapy (HAART). Once an individual requires HAART, researchers will evaluate the effects of initiating treatment on levels of the inflammatory markers.

There are four primary goals of this study:

  1. To characterize the levels of inflammatory biomarkers in treatment-naïve participants
  2. To determine the prognostic value of these biomarkers
  3. To understand the impact of herpes simplex virus type 2 (HSV-2) co-infection, HSV-2 treatment, and micronutrient/antioxidant supplementation on inflammation
  4. To evaluate the effects of initiating HAART on levels of inflammatory markers

Researchers will follow cohorts of treatment-naïve HIV-positive individuals who are currently enrolled in one of two CTN trials: CTN 240 (VALIDATE ) and CTN 238 (MAINTAIN).

About the disease/condition

The immune systems of people living with HIV infection create a large amount of inflammation. Inflammation is important in HIV because it may speed up disease progression, contribute to heart disease, kidney disease and liver disease, and shorten the time until HAART is needed. This inflammation can be detected using special blood tests that measure molecules called ‘inflammatory markers’. However, not enough is known about the usual levels of these inflammatory markers in HIV, especially among people not yet on HAART. It is also unknown whether HSV-2 infection, HSV-2 treatment, and supplements containing micronutrients (vitamins and minerals) and antioxidants (action of some micronutrients) may decrease inflammation and delay the need to start HAART.

About the approach/intervention

Researchers will aim to find the relationship, if any, between levels of four key biomarkers (IL-6, hsCRP, sICAM-1, LPS), and the rate of HIV disease progression to the need to start HAART. Once a participant initiates treatment, researchers will evaluate the effects of HAART on the inflammatory markers on a quarterly basis for one year; no intervention will be administered during this period.

The study analyses will account for any differences in inflammatory markers that might be related to the interventions received in the parent VALIDATE and MAINTAIN trials.

Eligibility criteria

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

Individuals will be eligible for this study if they meet the eligibility criteria for, and are enrolled in either the VALIDATE trial (CTN-240) or the MAINTAIN trial (CTN-238).

Participating sites

Participants will be recruited into the study across each province from various clinics, AIDS Service Organizations, social services such as shelters, and through online, peer outreach and other informal networks. If interested in participating or would like more information, please contact a Coordinator in your region.


Dr. John Gill
Southern Alberta HIV Clinic, Calgary
Ph: 403-234-2377

British Columbia

Dr. Brian Conway
Downtown IDC, Vancouver
Ph: 604-642-6429


Dr. Ken Kasper
St. Boniface General Hospital, Winnipeg
Ph: 204-787-3633


Dr. Sylvie Trottier
Centre de recherche en infectiologie du CHUL, Québec City
Ph: 418-654-2705

Dr. Richard Lalonde
Montreal Chest/Royal-Victoria, Montreal
Ph: 514-843-2090

AnitaDr. Danielle Rouleau
CHUM – Hôpital Notre-Dame, Montreal
Tel: 514-890-8000 x 24720

Nova Scotia

Dr. David Haase
Victoria General, Halifax
Ph: 902-473-8477


Dr. Bill Cameron
The Ottawa Hospital, Ottawa
Ph: 613-737-8209

Dr. Hugues Loemba
University of Ottawa Health Services, Ottawa
Ph: 613- 564-3950

Dr. Mona Loutfy
Maple Leaf Medical Clinic, Toronto
Ph: 416-465-0856

Dr. Anita Rachlis
Sunnybrook Health Sciences Centre, Toronto
Ph: 416-480-4689

Dr. Edward Ralph
St. Joseph’s Hospital, London
Ph: 519-646-6207

Dr. Roger Sandre
Haven Program, Sudbury
Ph: 705-523-7059

Dr. Fiona Smaill
McMaster University, Hamilton
Ph: 905-521-9800 ext. 76307

Dr. Darrell Tan
St. Michael’s Hospital, Toronto
Ph: 416-864-5568

Dr. Sharon Walmsley
Toronto General Hospital
Ph: 416-340-3871 /5077

Dr. Wendy Wobeser
Kingston General Hospital, Kingston
Ph: 613-533-2978

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigators

Dr. Mark Hull, Dr. Darrell Tan
St. Michael’s Hospital, Toronto
Ph: 416-864-5568

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