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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
        • Contact:
        • 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.

Sponsor

Shanghai Public Health Clinical Center

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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