- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03478540
Gut Microbiota and Immune Recovery
March 20, 2018 updated by: Hongzhou Lu, Shanghai Public Health Clinical Center
Impact of Gut Microbiota on the Immune Recovery in HIV-infection
To explore whether gut microbiota would impact CD4 T cells recovery in HIV-infected patients on antiretroviral therapy (ART).
We prospectively enroll patients initiate ART and collect their fecal at followup for one year.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Chen
- Phone Number: 3222 021-37990333
- Email: chenjun@shaphc.org
Study Contact Backup
- Name: Hongzhou Lu
- Phone Number: 3222 021-37990333
- Email: luhongzhou@fudan.edu.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201508
- Recruiting
- Shanghai Public Health Clinical Center
-
Contact:
- Jun Chen
- Phone Number: 3222 008602137990333
- Email: qtchenjun@163.com
-
Contact:
- Hongzhou Lu
- Phone Number: 3222 008602137990333
- Email: luhongzhou@fudan.edu.cn
-
Sub-Investigator:
- Jun Chen, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
HIV-infected patients initiating antiretroviral therapy with CD4 T cell counts< 350cells/mm3
Description
Inclusion Criteria:
- Confirmed HIV infection
- Antiretroviral therapy naive
- CD4 T cell counts<350cells/mm3
- Agree to participate
Exclusion Criteria:
- Don't want to start antiretroviral therapy
- Cocurrent cancer or opportunistic infection
- Liver diseases
- received antibiotics within four weeks of enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune recovery
Time Frame: 48 weeks
|
Cluster of differentiation 4 (CD4) T cells increased >25% or to higher than 350 cells/mm3
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV viral load
Time Frame: 48 weeks
|
Viral load below limitation of detection
|
48 weeks
|
Microbiota composition
Time Frame: week 0 and 48
|
Gut microbiota composition
|
week 0 and 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Anticipated)
May 30, 2019
Study Completion (Anticipated)
May 30, 2019
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 27, 2018
Study Record Updates
Last Update Posted (Actual)
March 27, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mic-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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