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NCT03478540 Clinical Trial

Gut Microbiota and Immune Recovery

HIV-1-infection Clinical Trial

Official title:
Impact of Gut Microbiota on the Immune Recovery in HIV-infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03478540
Other study ID # Mic-1
Secondary ID
Status Recruiting
Phase
First received March 20, 2018
Last updated March 20, 2018
Start date December 1, 2017
Est. completion date May 30, 2019

Study information
Verified date March 2018
Source Shanghai Public Health Clinical Center
Contact Jun Chen
Phone 021-37990333
Email chenjun@shaphc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date May 30, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Anti-Retroviral Agents
First line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz

Locations
Country Name City State
China Shanghai Public Health Clinical Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune recovery Cluster of differentiation 4 (CD4) T cells increased >25% or to higher than 350 cells/mm3 48 weeks
Secondary HIV viral load Viral load below limitation of detection 48 weeks
Secondary Microbiota composition Gut microbiota composition week 0 and 48
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