A prospective, randomised study to assess safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters over 48 weeks in HIV-1 infected subjects undergoing a switch in antiretroviral therapy. - The St. Marys and The Mater Switch Study (SMASH)

Phase 1

• Conditions: HIV

• Registration Number: EUCTR2009-011538-93-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Study Completion: 2013-03-29
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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 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
•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

•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

Study & Design

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