CompletedNot Applicable

Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

Kenya685 participantsStarted 2014-03

Plain-language summary

The aim of this study is to develop and follow a cohort of human immunodeficiency virus (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and urine samples will be collected from all participants in order to establish a sample bank of samples in order to further the understanding of the levels of inﬂammatory biomarkers and coagulation biomarkers in African patients and the effect of taking HIV drugs on these biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs and collect blood and urine specimens from them at 4 study visits. These samples will be frozen and stored for future testing related to inﬂammatory and coagulation biomarkers.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women at least 18 years of age * Known to be HIV positive * ART-naïve (with exception of prior exposure to single dose nevirapine in women) * Documented ART eligibility based on CD4+ cell count and/or WHO staging * Willing to provide locator information and to adhere to study procedures. * No intention of permanently moving away from area for coming 12 months Exclusion Criteria: * Individuals who do not meet the inclusion criteria outlined above * Women who are currently pregnant * Any condition which in the opinion of the investigators would interfere with participation in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L

Timeframe: Baseline to 12 months

Change in mean interleukin-6 (IL-6) levels measured in ng/mL

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT02027480

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-10

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