HIV (Human Immunodeficiency Virus)iMACSNCT02027480
Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study
An observational study of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immune Deficiency Syndrome), run by Columbia University at 9 sites in Kenya.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), AIDS (Acquired Immune Deficiency Syndrome), Tuberculosis
- How many people
- 685 participants
- Where
- 9 sitesKenya
- Study dates
- Mar 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Kenya9 sites
Ahero Sub District Hospital
Ahero, Nyanza
Ambira Sub District Hospital
Ambira, Nyanza
Awasi Mission
Awasi, Nyanza
Bondo District Hospital
Bondo, Nyanza
Nyakach District Hospital
Kisumu, Nyanza
Masogo Sub District Hospital
Masogo, Nyanza
Nyangoma Dispensary
Nyangoma, Nyanza
Sigomere Health Centre
Sigomere, Nyanza
Sondu Health Center
Sondu, Nyanza
About this study
Official title: Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort, iMACS Study
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.
Read the 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
- Conditions
- HIV (Human Immunodeficiency Virus), AIDS (Acquired Immune Deficiency Syndrome), Tuberculosis, Non-communicable Diseases (NCD)
- Keywords
- Antiretroviral Therapy (ART), Biomarkers, Nyanza Province, Kenya
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 12 months
Secondary outcomes (7)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Wafaa Mahmoud El-Sadr, Columbia University
- Investigators
- Wafaa M El-Sadr, MD/MPH, Principal investigator, ICAP-NY, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027480
- Sponsor's protocol ID
- AAAM2314
- Acronym
- iMACS
- Status last verified
- Dec 2015
- First submitted
- 2 Jan 2014
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort, iMACS Study
- ClinicalTrials.gov ID
- NCT02027480
- Acronym / sponsor ID
- iMACS / AAAM2314
- Conditions
- HIV (Human Immunodeficiency Virus), AIDS (Acquired Immune Deficiency Syndrome), Tuberculosis, Non-communicable Diseases (NCD)
- Keywords
- Antiretroviral Therapy (ART), Biomarkers, Nyanza Province, Kenya
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L
Time frame: Baseline to 12 months
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.
Change in mean interleukin-6 (IL-6) levels measured in ng/mL
Time frame: Baseline to 12 months
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.
7 secondary outcomes
Prevalence (% of participants) of smoking in the study population
Time frame: 12 months
Prevalence (% of participants) of high BMI in the study population
Time frame: 12 months
Prevalence (% of participants) of cotinine in blood in the study population.
Time frame: 12 months
Prevalence (% of participants) of hypertension in the study population.
Time frame: 12 months
Prevalence (% of participants) of diabetes in the study population.
Time frame: 12 months
Prevalence (% of participants) of overweight/obesity in the study population.
Time frame: 12 months
Prevalence (% of participants) of tuberculosis in the study population.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa M El-Sadr, MD/MPH principal investigator
ICAP-NY, Columbia University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immune Deficiency Syndrome), run by Columbia University at 9 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.