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NCT Number: NCT02027480

Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: 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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) AIDS (Acquired Immune Deficiency Syndrome) Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections Non-communicable Diseases (NCD) Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahero Sub District Hospital, Ahero, Nyanza, Kenya

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: iMACS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2014
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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