Gut Microbiota and Immune Recovery

• Conditions: HIV-1-infection

• Registration Number: NCT03478540
• Lead Sponsor: Shanghai Public Health Clinical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-20
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune recovery	48 weeks	Cluster of differentiation 4 (CD4) T cells increased \>25% or to higher than 350 cells/mm3

Secondary Outcome Measures

Name	Time	Method
HIV viral load	48 weeks	Viral load below limitation of detection
Microbiota composition	week 0 and 48	Gut microbiota composition

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China