Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT01049204
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01049204
Study Brief:
Protocol Section:
NCT01049204