NCT02027480|CompletedDMC
Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study
iMACS
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iMACS
Sponsor study identifier
observational
685
1 country
9
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2014
Actual (reported)January 6, 2014
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Actual (reported)October 2015
Actual (reported)Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L
Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers at four different times during this study to assess the change in marker levels.
Baseline to 12 months
Change in mean interleukin-6 (IL-6) levels measured in ng/mL
Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers at four different times during this study to assess the change in marker levels.
Baseline to 12 months
Prevalence (% of participants) of smoking in the study population
The study will be a prospective cohort study of HIV-infected adults initiating ART at 4-8 health facilities in Nyanza Province, Kenya. Participants will be asked to take part in four visits over a 12 month period. At each study visit, participants will be asked questions related to demographic characteristics, medical history, including history of/recent medical conditions, family medical history, TB history and smoking status. Participants will also have their height (at baseline visit only) and weight measured for calculation of BMI and blood pressure reading. Blood and urine specimens will be collected and stored at each study visit for future testing.
Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.
Ahero Sub District Hospital
Ahero, Nyanza, Kenya
Ambira Sub District Hospital
Ambira, Nyanza, Kenya
Awasi Mission
Awasi, Nyanza, Kenya
Bondo District Hospital
Bondo, Nyanza, Kenya
Nyakach District Hospital
Kisumu, Nyanza, Kenya
Masogo Sub District Hospital
Masogo, Nyanza, Kenya
Nyangoma Dispensary
Nyangoma, Nyanza, Kenya
Blood and urine samples will be collected from study participants at 4 different points during their 12 months of participation. 15 mL of blood and 10 mL of urine will collected via venipuncture at baseline, 2 months, 6 months, and 12 months. Specimens will be retained for 10 years.
Wafaa M El-Sadr, MD/MPH
ICAP-NY, Columbia University
685 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2014
First Posted
January 6, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
12 months
Prevalence (% of participants) of high BMI in the study population
12 months
Prevalence (% of participants) of cotinine in blood in the study population.
12 months
Prevalence (% of participants) of hypertension in the study population.
12 months
Prevalence (% of participants) of diabetes in the study population.
12 months
Contact the study team to confirm eligibility.
Sigomere Health Centre
Sigomere, Nyanza, Kenya
Sondu Health Center
Sondu, Nyanza, Kenya
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
December 24, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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