Gut Microbiota and Immune Recovery | NCT03478540

Studies
Gut Microbiota and Immune Recovery

NCT03478540

Sponsor

Shanghai Public Health Clinical Center

Status

Unknown status

Last Update Posted

Mar 27, 2018Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

HIV-1-infection

Interventions

Anti-Retroviral Agents

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

May 30, 2019Estimated

Completion Date

May 30, 2019Estimated

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Mar 20, 2018

First Posted Date

Mar 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2018

Last Update Posted Date

Mar 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongzhou Lu, Vice Director, Shanghai Public Health Clinical CenterPrincipal Investigator

Lead Sponsor

Shanghai Public Health Clinical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-Retroviral Agents	Drug	First line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
HIV viral load	Viral load below limitation of detection	48 weeks
Microbiota composition	Gut microbiota composition	week 0 and 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

HIV-infected patients initiating antiretroviral therapy with CD4 T cell counts< 350cells/mm3

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Chen	Contact	021-37990333	3222	chenjun@shaphc.org
Hongzhou Lu	Contact	021-37990333	3222	luhongzhou@fudan.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Public Health Clinical Center	Recruiting	Shanghai	Shanghai Municipality	201508	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D044966	Anti-Retroviral Agents

Ancestor Terms

ID	Term
D000998	Antiviral Agents
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided