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

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).

Background

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.

Study Approach

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.

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.

Eligibility Requirements

Required

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).

      Investigators

      Here’s who is leading this study.

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      Email ctninfo@ctnplus.ca.

      info@ctnplus.ca

      Participating Sites

      Southern Alberta HIV Clinic

      • Dr. John Gill
      • Calgary, AB
      • Contact Person
      • contact@email.com
      • 403-234-2377

      Downtown IDC

      • Dr. Brian Conway
      • Vancouver, BC
      • Contact Person
      • contact@email.com
      • 604-642-6429

      St. Boniface General Hospital

      • Dr. Ken Kasper
      • Winnipeg, MB
      • Contact Person
      • contact@email.com
      • 204-787-3633

      Centre de recherche en infectiologie du CHUL

      • Dr. Sylvie Trottier
      • Québec City, QC
      • Contact Person
      • contact@email.com
      • 418-654-2705

      Montreal Chest/Royal-Victoria

      • Dr. Richard Lalonde
      • Montréal, QC
      • Contact Person
      • contact@email.com
      • 514-843-2090

      CHUM – Hôpital Notre-Dame

      • Dr. Danielle Rouleau
      • Montréal, QC
      • Contact Person
      • contact@email.com
      • 514-890-8000 ex. 24720

      Victoria General

      • Dr. David Haase
      • Halifax, NS
      • Contact Person
      • contact@email.com
      • 902-473-8477

      The Ottawa Hospital

      • Dr. Bill Cameron
      • Ottawa, ON
      • Contact Person
      • contact@email.com
      • 613-737-8209

      University of Ottawa Health Services

      • Dr. Hugues Loemba
      • Ottawa, ON
      • Contact Person
      • contact@email.com
      • 613-564-3950

      Maple Leaf Medical Clinic

      • Dr. Mona Loutfy
      • Toronto, ON
      • Contact Person
      • contact@email.com
      • 416-465-0856

      Sunnybrook Health Sciences Centre

      • Dr. Anita Rachlis
      • Toronto, ON
      • Contact Person
      • contact@email.com
      • 416-480-4689

      St. Joseph’s Hospital

      • Dr. Edward Ralph
      • London, ON
      • Contact Person
      • contact@email.com
      • 519-646-6207

      Haven Program

      • Dr. Roger Sandre
      • Sudbury, ON
      • Contact Person
      • contact@email.com
      • 705-523-7059

      McMaster University

      • Dr. Fiona Smaill
      • Hamilton, ON
      • Contact Person
      • contact@email.com
      • 905-521-9800 ex. 76307

      St. Michael’s Hospital

      • Dr. Darrell Tan
      • Toronto, ON
      • Contact Person
      • contact@email.com
      • 416-864-5568

      Toronto General Hospital

      • Dr. Sharon Walmsley
      • Toronto, ON
      • Contact Person
      • contact@email.com
      • Toronto, ON
        416-340-3871 ex. 5077

      Kingston General Hospital

      • Dr. Wendy Wobeser
      • Kingston, ON
      • Contact Person
      • contact@email.com
      • 613-533-2978
      • 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

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