Antiretroviral Therapy & Inflammatory & Coagulation Biomarkers: iMACS

Status Completed

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.

Clinical Trial 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 ;

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

Clinical Trial Details

NCT number	NCT02027480
Study type	Observational
Source	Columbia University
Contact
Status	Completed
Phase	N/A
Start date	March 2014
Completion date	October 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study — iMACS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms