HIV
Conditions
Interventions
Product Name: maraviroc
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Maraviroc
CAS Number: 376348-65-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
St Stephen's Aids Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Each participant must meet the following criteria to be enrolled in this study: HIV-1 antibody positive On a virologically suppressive regimen for at least 24 weeks and stable on a PI/r (ATV, LPV or DRV) plus Truvada or Kivexa for at least 4 weeks prior to screening Current HIV-1 RNA 4 weeks apart No prior CCR5 or CXCR4 antagonist use Prior tetanus toxoid immunisation or known tetanus antibodies. Immunisation must have taken place in the past 10 years, but not within 1 month of baseline visit. Known CD4 nadir If the subject is a woman of child bearing potential, she must agree to use a double barrier method of contraception Willing and able to provide written informed consent At least 18 years old 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Immunologically active agents (any use of IL-2, GH or GHRH, corticosteroids (except inhaled), G- and GM-CSF) History of HIV, cholera or meningococcal immunisation Other known immune deficiency or use of immune suppressant History of malignancy (except low volume Kaposi’s sarcoma) or chemotherapy Contraindication to maraviroc Peanut or soya allergy Antiretroviral agents other than those in inclusion list Drugs known to reduce exposure to maraviroc (CYP3A inducers) Contraindication to vaccines or vaccine components and/or components of skin test kits Pregnant or lactating or planning to become pregnant during the study period Acute feverish, stomach or intestinal illness Received an investigational medicinal product as part of a clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The impact of the addition of Maraviroc on immune function.;Secondary Objective: The impact of addition of Maraviroc on immune response to immunisation with Cholera, Tetanus and Meningococcal and the Mantoux skin test. The effect of the addition of Maraviroc on safety parameters. ;Primary end point(s): The changes in tetanus antibody titres following vaccination. | — |
Countries
United Kingdom
Outcome results
None listed