Clinical trial NCT02027480: Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study
Official title: Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort, iMACS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV (Human Immunodeficiency Virus)
AIDS (Acquired Immune Deficiency Syndrome)
Tuberculosis
Non-communicable Diseases (NCD)
Keywords: Antiretroviral Therapy (ART)
Biomarkers
Nyanza Province
Kenya
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-01-06
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L
timeFrame: Baseline to 12 months
measure: Change in mean interleukin-6 (IL-6) levels measured in ng/mL
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Prevalence (% of participants) of smoking in the study population
timeFrame: 12 months
measure: Prevalence (% of participants) of high BMI in the study population
timeFrame: 12 months
measure: Prevalence (% of participants) of cotinine in blood in the study population.
timeFrame: 12 months
measure: Prevalence (% of participants) of hypertension in the study population.
timeFrame: 12 months
measure: Prevalence (% of participants) of diabetes in the study population.
timeFrame: 12 months
measure: Prevalence (% of participants) of overweight/obesity in the study population.
timeFrame: 12 months
measure: Prevalence (% of participants) of tuberculosis in the study population.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahero
country: Kenya
facility: Ahero Sub District Hospital
state: Nyanza
city: Ambira
country: Kenya
facility: Ambira Sub District Hospital
state: Nyanza
city: Awasi
country: Kenya
facility: Awasi Mission
state: Nyanza
city: Bondo
country: Kenya
facility: Bondo District Hospital
state: Nyanza
city: Kisumu
country: Kenya
facility: Nyakach District Hospital
state: Nyanza
city: Masogo
country: Kenya
facility: Masogo Sub District Hospital
state: Nyanza
city: Nyangoma
country: Kenya
facility: Nyangoma Dispensary
state: Nyanza
city: Sigomere
country: Kenya
facility: Sigomere Health Centre
state: Nyanza
city: Sondu
country: Kenya
facility: Sondu Health Center
state: Nyanza
Study officials:
affiliation: ICAP-NY, Columbia University
name: Wafaa M El-Sadr, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: