Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study (iMACS)

December 22, 2015 updated by: Wafaa Mahmoud El-Sadr, Columbia University

Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort, iMACS Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Biomarkers have been investigated as predictors of HIV disease progression, i.e. development of acquired immunodeficiency syndrome (AIDS) defining diagnoses or death. There are limited data on the levels of these biomarkers among HIV-infected individuals in sub Saharan Africa and on the effect of antiretroviral therapy (ART) initiation on these levels. In addition, further work is needed to examine the association between such markers and various complications associated with HIV as well as mortality in sub Saharan Africa. The overall aim of this study is to develop a cohort of HIV-infected adults who are initiating ART at health facilities in Kenya and to establish a sample bank of plasma and urine samples in order to further the understanding of the levels of inflammatory biomarkers (IBM) and coagulation biomarkers (CBM) in African patients and the effect of ART initiation on these biomarkers. The study objectives are as follows:

  • To recruit, establish and follow a cohort of HIV-infected individuals who are eligible for initiation of ART through 12 months
  • To obtain blood and urine samples on all cohort participants at baseline, months 2, 6, and 12 for future HIV and related research
  • To describe the demographic and disease characteristics of cohort participants and associations with various biomarkers

Study Type

Observational

Enrollment (Actual)

685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Nyanza
      • Ahero, Nyanza, Kenya
        • Ahero Sub District Hospital
      • Ambira, Nyanza, Kenya
        • Ambira Sub District Hospital
      • Awasi, Nyanza, Kenya
        • Awasi Mission
      • Bondo, Nyanza, Kenya
        • Bondo District Hospital
      • Kisumu, Nyanza, Kenya
        • Nyakach District Hospital
      • Masogo, Nyanza, Kenya
        • Masogo Sub District Hospital
      • Nyangoma, Nyanza, Kenya
        • Nyangoma Dispensary
      • Sigomere, Nyanza, Kenya
        • Sigomere Health Centre
      • Sondu, Nyanza, Kenya
        • Sondu Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prospective Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L
Time Frame: Baseline to 12 months
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
Time Frame: Baseline to 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence (% of participants) of smoking in the study population
Time Frame: 12 months
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
12 months
Prevalence (% of participants) of high BMI in the study population
Time Frame: 12 months
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
12 months
Prevalence (% of participants) of cotinine in blood in the study population.
Time Frame: 12 months
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
12 months
Prevalence (% of participants) of hypertension in the study population.
Time Frame: 12 months
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
12 months
Prevalence (% of participants) of diabetes in the study population.
Time Frame: 12 months
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
12 months
Prevalence (% of participants) of overweight/obesity in the study population.
Time Frame: 12 months
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
12 months
Prevalence (% of participants) of tuberculosis in the study population.
Time Frame: 12 months
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAM2314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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