ART and Inflammatory and Coagulation Biomarkers (ARTIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wafaa Mahmoud El-Sadr, Columbia University
ClinicalTrials.gov Identifier:
NCT02027480
First received: January 2, 2014
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in inflammatory and coagulation markers [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers, including high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6), at four different times during this study to assess the change in marker levels.


Secondary Outcome Measures:
  • Prevalence of risk factors for noncommunicable diseases (NCDs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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, e.g. smoking, high BMI, cotinine in blood, family history.

  • Prevalence of co-morbid conditions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions including hypertension, diabetes, cardiovascular disease, overweight /obesity, and tuberculosis.


Biospecimen Retention:   Samples With DNA

Blood and urine samples will be collected from study participants at 4 different points during their 12 months of participation. 15 mL of blood and 10 mL of urine will collected via venipuncture at baseline, 2 months, 6 months, and 12 months. Specimens will be retained for 10 years.


Estimated Enrollment: 685
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Study participants must meet all of the inclusion criteria to participate in this study:
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027480

Contacts
Contact: Wafaa M El-Sadr, MD/MPH 212-342-0505 wme1@columbia.edu
Contact: Allison Zerbe, MPH 212-342-3154 az2258@columbia.edu

Locations
Kenya
Ahero Sub District Hospital Recruiting
Ahero, Nyanza, Kenya
Ambira Sub District Hospital Recruiting
Ambira, Nyanza, Kenya
Awasi Mission Recruiting
Awasi, Nyanza, Kenya
Bondo District Hospital Recruiting
Bondo, Nyanza, Kenya
Nyakach District Hospital Active, not recruiting
Kisumu, Nyanza, Kenya
Masogo Sub District Hospital Recruiting
Masogo, Nyanza, Kenya
Nyangoma Dispensary Recruiting
Nyangoma, Nyanza, Kenya
Sigomere Health Centre Recruiting
Sigomere, Nyanza, Kenya
Sondu Health Center Active, not recruiting
Sondu, Nyanza, Kenya
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Wafaa M El-Sadr, MD/MPH ICAP-NY, Columbia University
  More Information

No publications provided

Responsible Party: Wafaa Mahmoud El-Sadr, University Professor; Director, ICAP, Columbia University
ClinicalTrials.gov Identifier: NCT02027480     History of Changes
Other Study ID Numbers: AAAM2314
Study First Received: January 2, 2014
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Antiretroviral Therapy (ART)
Biomarkers
Nyanza Province
Kenya

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Lentivirus Infections
Mycobacterium Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014