CTN 254: Inflammation as a predictor of HIV disease progression

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

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.