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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02027480
Other study ID # AAAM2314
Secondary ID
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


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
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