The St. Marys and The Mater Switch Study - Full Text View

Sponsor:	Imperial College London
Collaborator:	Mater Hospital Dublin
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00981773

Purpose

The aim of the study is to determine whether switching from an antiretroviral regimen containing abacavir and/or didanosine to one containing maraviroc will lead to a reduction in platelet reactivity and inflammatory markers at weeks 12 and 24 thereby conferring a reduction in cardiac risk.

In addition the study will assess the efficacy of a maraviroc containing regimen in combination with a boosted protease inhibitor in terms of tolerability and achieving long term viral suppression as assessed at week 48.

The investigators hypothesize that there will be a rapid reduction in platelet reactivity on switching to maraviroc and that a boosted protease inhibitor in combination with maraviroc will provide a safe and efficacious antiretroviral regimen enabling a reduction in cardiac risk whilst maintaining virological suppression.

Condition	Intervention	Phase
HIV Infections	Drug: Maraviroc	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomised Study to Assess Safety, Changes in Platelet Reactivity, Plasma Cardiac Biomarkers, Immunological and Metabolic Parameters in HIV-1 Infected Subjects Undergoing a Switch in Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Mean change from baseline in platelet reactivity between treatment arms at week 12 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess for the following: Mean change over 24 weeks and mean difference at week 12 between study groups in plasma inflammatory and cardiac biomarkers and markers of immune activation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2009

Arms	Assigned Interventions
Immediate switch: Experimental Continue current boosted protease inhibitor Switch NRTI backbone to maraviroc 150 mg bid	Drug: Maraviroc Maraviroc 150 mg bid
Continue current antiretroviral therapy: Active Comparator Continue current antiretroviral regimen until week 12 then switch therapy as per arm 1.	Drug: Maraviroc maraviroc 150 mg bid switch 12 weeks later

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 infected males or females
Between 18 and 65 years of age
Signed informed consent
Currently receiving a stable antiretroviral regimen comprising of:
- two licensed NRTIs including abacavir and/or didanosine
- any licensed boosted protease inhibitor at any dose (excluding tipranavir*)
Undetectable plasma HIV RNA to less than 50 copies/mL for at least 24 weeks prior to screening
Availability of stored plasma with which to perform a tropism assay
CCR5 tropic HIV virus based on a tropism assay from a stored plasma sample
Willing to continue unchanged, or to modify antiretroviral therapy, in accordance with the randomisation assignment
No documented viral resistance to currently licensed HIV-1 protease inhibitors based either on previous HIV-1 genotypic resistance testing or in the judgement of the study investigators
No previous exposure to maraviroc or CCR5 receptor antagonists
Subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator
Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must avoid becoming pregnancy as follows from screening through completion of the study using one or both of the following methods:
- barrier contraceptives (condom, diaphragm with spermicide)
- IUD PLUS a barrier contraceptive
Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

failure of current antiretroviral regimen due to virological failure
active opportunistic infection, malignancy or significant co-morbidities in the opinion of the investigator
pregnancy
current prohibited concomitant medication (as listed in section 4.1.4)
no available stored plasma sample predating their current antiretroviral regimen upon which a tropism assay can be performed
active HBV infection as evidenced by positive hepatitis B surface antigen
active hepatitis C virus infection as evidenced by positive HCV PCR or HCV antibody.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981773

Contacts

Contact: Alan Winston, MBChB	+44 20 7886 1603	a.winston@imperial.ac.uk
Contact: Kenneth R Legg, BSc	44 20 7886 1464	k.legg@imperial.ac.uk

Locations

Ireland
Mater Misericordiae University Hospital	Recruiting
Dublin, Ireland
Contact: Claudette Satchell
Principal Investigator: Patrick Mallon

Sponsors and Collaborators

Imperial College London

Mater Hospital Dublin

Investigators

Principal Investigator:	Alan Winston, MBChB	Imperial College London
Principal Investigator:	Patrick Mallon, MBChB	UCD School of Medicine and Medical Sciences

More Information

No publications provided

Responsible Party:	Imperial College London ( Dr Alan Winston )
Study ID Numbers:	1.0 18.6.2009
Study First Received:	September 21, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00981773 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:

HIV switch
HIV
treatment experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010