Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

NCT02027480 | Completed DMC

• 1 other identifier: AAAM2314
• Study Type: observational
• Target: 685
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Keywords

Antiretroviral Therapy (ART); Biomarkers; Nyanza Province; Kenya

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Prevalence (% of participants) of smoking in the study population

  12 months

• Prevalence (% of participants) of high BMI in the study population

  12 months

• Prevalence (% of participants) of cotinine in blood in the study population.

  12 months

• Prevalence (% of participants) of hypertension in the study population.

  12 months

• Prevalence (% of participants) of diabetes in the study population.

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Women who are currently pregnant
• Any condition which in the opinion of the investigators would interfere with participation in the study

Sponsors & Collaborators

• Columbia University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (9)

Ahero Sub District Hospital

Ahero, Nyanza, Kenya

Location

Ambira Sub District Hospital

Ambira, Nyanza, Kenya

Location

Awasi Mission

Awasi, Nyanza, Kenya

Location

Bondo District Hospital

Bondo, Nyanza, Kenya

Location

Nyakach District Hospital

Kisumu, Nyanza, Kenya

Location

Masogo Sub District Hospital

Masogo, Nyanza, Kenya

Location

Nyangoma Dispensary

Nyangoma, Nyanza, Kenya

Location

Sigomere Health Centre

Sigomere, Nyanza, Kenya

Location

Sondu Health Center

Sondu, Nyanza, Kenya

Location

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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wafaa M El-Sadr, MD/MPH

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor; Director, ICAP

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

KE (9)