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Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

NCT ID: NCT02027480

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

685 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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

Conditions

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

Keywords

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Antiretroviral Therapy (ART) Biomarkers Nyanza Province Kenya

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

* Women who are currently pregnant
* Any condition which in the opinion of the investigators would interfere with participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Wafaa Mahmoud El-Sadr

University Professor; Director, ICAP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wafaa M El-Sadr, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

ICAP-NY, Columbia University

Locations

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Ahero Sub District Hospital

Ahero, Nyanza, Kenya

Site Status

Ambira Sub District Hospital

Ambira, Nyanza, Kenya

Site Status

Awasi Mission

Awasi, Nyanza, Kenya

Site Status

Bondo District Hospital

Bondo, Nyanza, Kenya

Site Status

Nyakach District Hospital

Kisumu, Nyanza, Kenya

Site Status

Masogo Sub District Hospital

Masogo, Nyanza, Kenya

Site Status

Nyangoma Dispensary

Nyangoma, Nyanza, Kenya

Site Status

Sigomere Health Centre

Sigomere, Nyanza, Kenya

Site Status

Sondu Health Center

Sondu, Nyanza, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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AAAM2314

Identifier Type: -

Identifier Source: org_study_id