HIV
Conditions
Interventions
Study subjects will receive either maraviroc or placebo.
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. HAART with a maximal treatment interruption of two weeks; 3. viral suppression (< 50 copies/ml) for 6 months. And either: CD4+ count < 200 cells/microl after minimal one year of treatment with HAART (study group one). Or: a CD4+ cell count between 200 and 350 cells/microl after minimal two years of treatment with HAART (studygroup two).
Exclusion criteria
Exclusion criteria: 1. HAART consisting of a combination of tenofovir and didanosine; 2. Active infection for which antimicrobial treatment; 3. Acute hepatitis B or C; 4. Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirine; (Note: patients with untreated chronic hepatitis B or C can be included); 5. Immunosuppressive medication; 6. Radiotherapy or chemotherapy in the past 2 years; 7. Pregnancy or breastfeeding an infant; 8. Subjects with known hypersensitivity to maraviroc or to peanuts, or any of its excipients or dyes as follows: a. Excipiens from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. b. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30% increase in CD4 cell count compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plasma HIV RNA. | — |
Contacts
Public ContactS. Lelyveld, van
Universitair Medisch Centrum Utrecht Postbus 85500 Huispostnummer F.02.126 088-7555555, sein 3811
Outcome results
None listed