Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

Tuberculosis Clinical Trial

— iMACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027480
• Other study ID #: AAAM2314
• Status: Completed
• Phase: N/A
• First received: January 2, 2014
• Last updated: December 22, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS (Acquired Immune Deficiency Syndrome)
• HIV (Human Immunodeficiency Virus)
• HIV Infections
• Immunologic Deficiency Syndromes
• Non-communicable Diseases (NCD)
• Tuberculosis

Locations

Country	Name	City	State
Kenya	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	Sigomere Health Centre	Sigomere	Nyanza
Kenya	Sondu Health Center	Sondu	Nyanza

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institutes of Health (NIH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Prevalence (% of participants) of smoking in the study population	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	No
Secondary	Prevalence (% of participants) of high BMI in the study population	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	No
Secondary	Prevalence (% of participants) of cotinine in blood in the study population.	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	No
Secondary	Prevalence (% of participants) of hypertension in the study population.	Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.	12 months	No
Secondary	Prevalence (% of participants) of diabetes in the study population.	Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.	12 months	No
Secondary	Prevalence (% of participants) of overweight/obesity in the study population.	Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.	12 months	No
Secondary	Prevalence (% of participants) of tuberculosis in the study population.	Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.	12 months	No