Impact of Maraviroc on the Immune Function in HIV-1 Infected Subjects Receiving Immunisation With Novel Antigens

This study has been 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.)

Sponsor:

Information provided by (Responsible Party):

St Stephens Aids Trust

ClinicalTrials.gov Identifier:

NCT01049204

First received: January 12, 2010

Last updated: October 31, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention	Phase
HIV Infections	Drug: Maraviroc Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:

Changes in tetanus antibody titres following vaccination [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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 ]


Enrollment:	48
Study Start Date:	July 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 )
Study First Received:	January 12, 2010
Last Updated:	October 31, 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

ClinicalTrials.gov processed this record on September 21, 2017

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