E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The impact of the addition of Maraviroc on immune function. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <50cps/ml plasma on 2 occasions >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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The changes in tetanus antibody titres following vaccination. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |