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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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ClinicalTrials.gov Identifier: NCT01049204
Recruitment Status : Terminated (The data from the first 48 patients recruited has now been analysed, and it has been determined that it is sufficient to meet the study objectives.)
First Posted : January 14, 2010
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust

Study Description
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Brief Summary:

Impact of Maraviroc, a ART CCR5 inhibitor, on the intensification of immune function in HIV-1 infected subjects receiving immunisation with novel antigens

The purpose of the study is to investigate the impact of adding Maraviroc (an anti-HIV agent) to a participant's normal HIV medication, on immune function. As part of the study participants will also receive three different vaccinations and a skin test. The study will also look at whether Maraviroc influences the body's response to these.

The vaccines are given to stimulate the body's immune system, so we can therefore evaluate the impact that Maraviroc has on this.

The duration of the study will be just over 24 weeks plus a screening period up to 4 weeks prior to the start of the study.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Maraviroc Drug: placebo Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
Nadir CD4 count >200 cells/µl blood and randomised to Maraviroc 150mg BD
 Drug: Maraviroc
Maraviroc 150 mg twice daily for 24 weeks
Other Name: Celsentri
Placebo Comparator: Group 2
Nadir CD4 count >200 cells/µl blood and randomised to placebo twice daily for 24 weeks
 Drug: placebo
Placebo twice daily for 24 weeks
Active Comparator: Group 3
Nadir CD4 count ≤200 cells/µl blood and randomised to Maraviroc 150mg BD
 Drug: Maraviroc
Maraviroc 150 mg twice daily for 24 weeks
Other Name: Celsentri
Placebo Comparator: Group 4
Nadir CD4 count ≤200 cells/µl blood and randomised to placebo twice daily for 24 weeks
 Drug: placebo
Placebo twice daily for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Changes in tetanus antibody titres following vaccination [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Changes in composite lymphocyte proliferation responses by group [ Time Frame: 24 weeks ]
  2. CD4 and CD8 subsets, activation and co-stimulation markers, plasma RNA viral load (pVL) [ Time Frame: 24 weeks ]
  3. Response to oral and subcutaneous neoantigens and recall antigens [ Time Frame: 24 weeks ]
  4. Influence on CCR5 antagonism on CD4 follicular T-cell counts and function [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049204


Locations
United Kingdom
St Stephen's Centre
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Graeme Moyle St Stephen's AIDS Trust
More Information
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Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01049204     History of Changes
Other Study ID Numbers: SSAT 030
EudraCT No. 2008-006769-95 ( Other Identifier: EU Clinical Trials database )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by St Stephens Aids Trust:
HIV
HIV-1 Infections

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
 Maraviroc
Immunologic Factors
Physiological Effects of Drugs
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents