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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00875368
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* HAART with a maximal treatment interruption of two weeks
* viral suppression (\< 50 copies/ml) for 6 months
* And either:
* CD4+ count \< 200 cells/microliter after minimal one year of treatment with HAART (study group one) OR
* a CD4+ cell count between 200 and 350 cells/microliter after minimal two years of treatment with HAART (study group two)
Exclusion Criteria:
* HAART consisting of a combination of tenofovir and didanosine
* Active infection for which antimicrobial treatment
* Acute hepatitis B or C
* Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirin (Note: patients with untreated chronic hepatitis B or C can be included)
* Immunosuppressive medication
* Radiotherapy or chemotherapy in the past 2 years
* Pregnancy or breastfeeding an infant
* Subjects with known hypersensitivity to maraviroc or to peanuts, or any of its excipients or dyes as follows:
* Excipients from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate.
* Film-coat: \[Opadry II Blue (85G20583) contains FD\&C blue #2 aluminium lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00875368
Study Brief:
Protocol Section:
NCT00875368