The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery; the ssecondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A 30% increase in CD4 cell rise in the treatment group (compared with placebo).
Secondary outcome
not applicable.
Background summary
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 patients, the so called
*immunologic non responders*, fail to reach an acceptable CD4 cell increase
despite an adequate virologic response on antiretroviral treatment. Recently a
new antiretroviral agent, Maraviroc (Celsentry®), is registered for the
treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is
available suggesting that treatment with Maraviroc leads to immune recovery
(increase in CD4 cells) in patients who are infected with dual/mixed tropic
HIV-1 virus, in the absence of a virologic response. This suggests an
alternative mechanism for immune recovery, which could be especially beneficial
for this group of patients.
Study objective
The primary objective is to confirm the hypothesis that Maraviroc stimulates
immune recovery; the ssecondary objective is to explore, by virologic and
immunologic investigations, the underlying mechanisms of this hypothesis.
Study design
Double blind placebo controlled trial.
Intervention
One group receives Maraviroc (dose dependent on co-medication), the other group
placebo.
Patients of UMC Utrecht who participate in research with deuterium oxide
('heavy water') will be asked to drink deuterium oxide.
Study burden and risks
1. In the treatment group subjects will start with a registered antiretroviral
agent (Maraviroc).
2. During the treatment year patients will perform several study visits,
probably three more compared with regular
visits on the outpatient clinic.
3. Each visit, blood will be drawn by venapuncture for immunologic and
virologic investigations (see flow chart).
4. Patients of UMC Utrecht who participate in research with
deuterium oxide ('heavy water') will be asked to drink
deuterium oxide. Also, extra blood will be taken by
venapunctions in these patients and urine analysis will be
performed.
Heidelberglaan 100
3508 GA Utrecht
NL
Heidelberglaan 100
3508 GA Utrecht
NL
Listed location countries
Age
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:
-CD+ 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
-Previous use of maraviroc
-HIV-2 infection
-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 ribavirine
(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:
• Excipiens 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003635-20-NL |
| CCMO | NL24441.041.08 |