NCT03478540

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 20, 2018

Last Update Submit

March 20, 2018

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • Immune recovery

    Cluster of differentiation 4 (CD4) T cells increased \>25% or to higher than 350 cells/mm3

    48 weeks

Secondary Outcomes (2)

  • HIV viral load

    48 weeks

  • Microbiota composition

    week 0 and 48

Interventions

Anti-Retroviral AgentsDRUG

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Confirmed HIV infection
  • Antiretroviral therapy naive
  • CD4 T cell counts\<350cells/mm3
  • Agree to participate

You may not qualify if:

  • Don't want to start antiretroviral therapy
  • Cocurrent cancer or opportunistic infection
  • Liver diseases
  • received antibiotics within four weeks of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

MeSH Terms

Interventions

Anti-Retroviral Agents

Intervention Hierarchy (Ancestors)

Antiviral AgentsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Jun Chen

CONTACT

021-37990333chenjun@shaphc.org

Hongzhou Lu

CONTACT

021-37990333luhongzhou@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

December 1, 2017

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)