The St. Marys and The Mater Switch Study

NCT00981773 | Terminated Phase 4

• 1 other identifier: 1.0 18.6.2009
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV switch; HIV; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in platelet reactivity between treatment arms at week 12

  48 weeks

Secondary Outcomes (1)

• 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

  48 weeks

Study Arms (2)

Immediate switch

EXPERIMENTAL

* Continue current boosted protease inhibitor * Switch NRTI backbone to maraviroc 150 mg bid

Drug: Maraviroc

Continue current antiretroviral therapy

ACTIVE COMPARATOR

* Continue current antiretroviral regimen until week 12 then switch therapy as per arm 1.

Drug: Maraviroc

Interventions

Maraviroc DRUG

Maraviroc 150 mg bid

Immediate switch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Mater Misericordiae University Hospital: collaborator

Study Sites (3)

Cork University Hospital

Cork, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alan Winston, MBChB

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Patrick Mallon, MBChB

  UCD School of Medicine and Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

GB (1); IE (2)