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Gut Microbiota and Immune Recovery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03478540
Enrollment
80
Registered
2018-03-27
Start date
2017-12-01
Completion date
2019-05-30
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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.

Interventions

First line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz

Sponsors

Shanghai Public Health Clinical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Immune recovery48 weeksCluster of differentiation 4 (CD4) T cells increased \>25% or to higher than 350 cells/mm3

Secondary

MeasureTime frameDescription
HIV viral load48 weeksViral load below limitation of detection
Microbiota compositionweek 0 and 48Gut microbiota composition

Countries

China

Contacts

Primary ContactJun Chen
chenjun@shaphc.org021-37990333
Backup ContactHongzhou Lu
luhongzhou@fudan.edu.cn021-37990333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026