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

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Stephens Aids Trust
• Treatments: Maraviroc; Vaccines

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