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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01049204 |
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Date of registration:
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12/01/2010 |
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Primary sponsor: |
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Public title:
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Impact of Maraviroc on the Immune Function in HIV-1 Infected Subjects Receiving Immunisation With Novel Antigens
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Scientific title:
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Randomised, Placebo Controlled, Phase IV, Safety and Exploratory Immunogenicity Study on Maraviroc, an Oral ART CCR5 Inhibitor, on the Intensification of Immune Function in HIV-1 Infected Subjects Receiving Immunisation With Novel Antigens |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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48 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01049204 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Graeme Moyle |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Stephen's AIDS Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Current or prior immunologically active agents (use of IL-2, GH or GHRH,
corticosteroids (except inhaled), G- and GM-CSF) deemed to potentially impact study
results.
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Maraviroc
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Drug: placebo
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Primary Outcome(s)
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Changes in tetanus antibody titres following vaccination
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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CD4 and CD8 subsets, activation and co-stimulation markers, plasma RNA viral load (pVL)
[Time Frame: 24 weeks]
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Changes in composite lymphocyte proliferation responses by group
[Time Frame: 24 weeks]
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Influence on CCR5 antagonism on CD4 follicular T-cell counts and function
[Time Frame: 24 weeks]
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Response to oral and subcutaneous neoantigens and recall antigens
[Time Frame: 24 weeks]
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Secondary ID(s)
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EudraCT No. 2008-006769-95
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SSAT 030
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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