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

NCT01049204 | Terminated Phase 4

• 2 other identifiers: SSAT 030EudraCT No. 2008-006769-95
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; HIV-1 Infections

Outcome Measures

Primary Outcomes (1)

• Changes in tetanus antibody titres following vaccination

  24 weeks

Secondary Outcomes (4)

• Changes in composite lymphocyte proliferation responses by group

  24 weeks

• CD4 and CD8 subsets, activation and co-stimulation markers, plasma RNA viral load (pVL)

  24 weeks

• Response to oral and subcutaneous neoantigens and recall antigens

  24 weeks

• Influence on CCR5 antagonism on CD4 follicular T-cell counts and function

  24 weeks

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Nadir CD4 count \>200 cells/µl blood and randomised to Maraviroc 150mg BD

Drug: Maraviroc

Group 2

PLACEBO COMPARATOR

Nadir CD4 count \>200 cells/µl blood and randomised to placebo twice daily for 24 weeks

Drug: placebo

Group 3

ACTIVE COMPARATOR

Nadir CD4 count ≤200 cells/µl blood and randomised to Maraviroc 150mg BD

Drug: Maraviroc

Group 4

PLACEBO COMPARATOR

Nadir CD4 count ≤200 cells/µl blood and randomised to placebo twice daily for 24 weeks

Drug: placebo

Interventions

Maraviroc DRUG

Maraviroc 150 mg twice daily for 24 weeks

Also known as: Celsentri

Group 1; Group 3

placebo DRUG

Placebo twice daily for 24 weeks

Group 2; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephen's Centre

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Graeme Moyle

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

GB (1)