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Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects

NCT ID: NCT03660722

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-02-29

Brief Summary

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Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.

Detailed Description

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Conditions

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HIV Positive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood and urinary sample

Blood and urinary sample in HIV 1 positive adults initiating treatment

Group Type OTHER

blood and urinary samples

Intervention Type OTHER

blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks

Interventions

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blood and urinary samples

blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV-1 positive
* Age 18-64 years
* Able to give informed consent
* Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Due to commence antiretroviral therapy by treating clinician

Exclusion Criteria

* \- Previous major intestinal surgery/inflammatory bowel conditions
* Infective diarrhoea in the last 3 months
* BMI\<18.5
* Currently pregnant OR planning to conceive during the study period
* Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amandine GAGNEUX-BRUNON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2018-001358-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1708212

Identifier Type: -

Identifier Source: org_study_id