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
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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 |

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 |

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
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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
|
- Changes in tetanus antibody titres following vaccination [ Time Frame: 24 weeks ]
- Changes in composite lymphocyte proliferation responses by group [ Time Frame: 24 weeks ]
- CD4 and CD8 subsets, activation and co-stimulation markers, plasma RNA viral load (pVL) [ Time Frame: 24 weeks ]
- Response to oral and subcutaneous neoantigens and recall antigens [ Time Frame: 24 weeks ]
- Influence on CCR5 antagonism on CD4 follicular T-cell counts and function [ Time Frame: 24 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United Kingdom | |
St Stephen's Centre | |
London, United Kingdom, SW10 9NH |
Principal Investigator: | Graeme Moyle | St Stephen's AIDS Trust |
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 |