Trial to investigating the effect of Maraviroc on movement of microbes across the gut wall in HIV-1 infected individuals who are receiving antiretroviral therapy

Phase 1

• Conditions: HIV; MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-023625-38-GB
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Study Completion: 2014-10-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1.Males and females aged between 18-64 stable on antiretroviral therapy for at least 12 months.
2.Screening CD4+ T cell count below 500 cells/mm.3
3.Screening plasma HIV RNA levels below 100 copies RNA/mL.
4.Ability and willingness of subject to give provide informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects unlikely to comply with protocol.
•Subjects who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
•Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
•Active Hep C (IgG and RNA positive)
•Hepatitis B(sAg positive) which will require treatment in the subsequent 24 weeks.
•Estimated creatinine clearance <40 mL/minute.
•Pregnant or breastfeeding women.
•Women of childbearing potential, unwilling to use barrier method contraception (condoms)
•Sexually active males with female partners of childbearing potential, unwilling to use barrier method contraception (condoms)
•Use of Maraviroc in current antiretroviral therapy regimen.
•Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
•Documented severe liver hepatic impairment.
•Hypersensitivity to the active substance or to peanut or soya or to any of the excipients

•Documented bleeding disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: To determine whether the addition of a CCR5 inhibitor to a stable ART regimen:<br> <br> Reduces immune activation<br> Reduces HIV reservoir<br> Increases immune reconstitution in the gut <br> Improves neurocognitive function<br> ;Primary end point(s): Level of Microbial translocation as quantified by bacterial 16s DNA PCR at week 24.;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: To determine whether the addition of a CCR5 inhibitor to a stable ART regimen reduces microbial translocation (as determined by plasma bacterial 16s DNA)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -Level of gut permeability: changes in level of CD14a<br> -Immune activation: changes in levels of CD8+CD38+<br> -Clinical outcome: CD4+ T cell count change and HIV plasma viral load change.<br> -Biomarkers of inflammation: levels of D-dimer<br> -Low copy HIV viral quantification <br> -Neurocognitive function: memory tests<br> -Gut immune reconstitution : Immunohistochemistry <br> ;Timepoint(s) of evaluation of this end point: 24 weeks