HIV
Conditions
Interventions
Trade Name: Maraviroc
Product Name: Maraviroc
Product Code: EU/1/07/418/001-010
Pharmaceutical Form: Film-coated tablet
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV-1 infected males or females • Over 18 years of age • Signed informed consent • Currently receiving a stable antiretroviral regimen comprising of two licensed NRTIs including abacavir and/or didanosine and 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 • Have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection by a HCV antibody or HCV PCR. • 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)or IUD PLUS a barrier contraceptive • Female subjects of childbearing potential must have a negative pregnancy test. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • no available stored plasma sample predating their current antiretroviral regimen upon which a tropism assay can be performed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 reduction in platelet reactivity at 12 and 24 weeks therby conferring a reduction in risk of heart attack.;Secondary Objective: 1) Change over 24 weeks and difference between study groups in markers of inflammation and measures of cardiac risk. 2) Mean change over 48 weeks and mean difference at week 12 and 24 between study groups in lipid parameters (cholesterol and triglyceride levels). 3) Percentage of patients with undetectable HIV viral load over 48 weeks. Time to failure of antiretroviral regimen. 4) Change from baseline of absolute CD4 cell count over 48 weeks. 5) Patterns of HIV resistance to antiretroviral medication associated with treatment failure over 48 weeks. 6) To describe maraviroc plasma drug levels over 48 weeks when dosed with different boosted protease inhibitors.;Primary end point(s): Mean change from baseline in platelet reactivity between treatment arms at week 12 | — |
Countries
Ireland, United Kingdom
Outcome results
None listed