HIV-1-infectionNCT03478540
Gut Microbiota and Immune Recovery
An observational study of HIV-1-infection, run by Shanghai Public Health Clinical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Anti-Retroviral Agents
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: HIV-infected patients initiating antiretroviral therapy with CD4 T cell counts< 350cells/mm3
Who may be able to join
- Confirmed HIV infection
- Antiretroviral therapy naive
- CD4 T cell counts<350cells/mm3
- Agree to participate
Who cannot join
- Don't want to start antiretroviral therapy
- Cocurrent cancer or opportunistic infection
- Liver diseases
- received antibiotics within four weeks of enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Jun Chen, 008602137990333 ext. 3222, qtchenjun@163.com
Hongzhou Lu, 008602137990333 ext. 3222, luhongzhou@fudan.edu.cn
About this study
Official title: Impact of Gut Microbiota on the Immune Recovery in HIV-infection
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.
- Conditions
- HIV-1-infection
- Being tested
- Anti-Retroviral Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Retroviral AgentsDrug
First line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune recovery
Cluster of differentiation 4 (CD4) T cells increased >25% or to higher than 350 cells/mm3
Measured: 48 weeks
Secondary outcomes (2)
HIV viral load
Viral load below limitation of detection
Measured: 48 weeks
Microbiota composition
Gut microbiota composition
Measured: week 0 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Dec 2017
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478540
- Sponsor's protocol ID
- Mic-1
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gut Microbiota on the Immune Recovery in HIV-infection
- ClinicalTrials.gov ID
- NCT03478540
- Acronym / sponsor ID
- Mic-1
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- HIV-infected patients initiating antiretroviral therapy with CD4 T cell counts< 350cells/mm3
Key inclusion criteria (4 listed)
- Confirmed HIV infection
- Antiretroviral therapy naive
- CD4 T cell counts<350cells/mm3
- Agree to participate
Key exclusion criteria (4 listed)
- Don't want to start antiretroviral therapy
- Cocurrent cancer or opportunistic infection
- Liver diseases
- received antibiotics within four weeks of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Retroviral AgentsFirst line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz | Drug | – |
Primary outcome
Immune recovery
Time frame: 48 weeks
Cluster of differentiation 4 (CD4) T cells increased >25% or to higher than 350 cells/mm3
2 secondary outcomes
HIV viral load
Time frame: 48 weeks
Microbiota composition
Time frame: week 0 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen (021-37990333 ext. 3222, chenjun@shaphc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune recovery (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.