Status:
COMPLETED
Maraviroc Immune Recovery Study
Lead Sponsor:
S.F.L. van Lelyveld
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A certain group of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00875368
Start Date
February 1 2009
End Date
August 1 2012
Last Update
September 10 2013
Active Locations (10)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 AC
2
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105AZ
3
Slotervaartziekenhuis
Amsterdam, Netherlands
4
Rijnstate Hospital
Arnhem, Netherlands