Maraviroc Immune Recovery Study

NCT00875368

Last updated date
Study Location
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 AC, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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NCT00875368
  1. Amsterdam,
  2. Amsterdam,
  3. Amsterdam,
  4. Arnhem,
  5. Haarlem,
  6. Leiden,
  7. Rotterdam,
  8. Rotterdam,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Maraviroc Immune Recovery Study
Official Title  ICMJE Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery
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 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.

Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing CD4+ cell count.

Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates immune recovery; the secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.

Study design: multicentre, randomized, placebo-controlled, double blind, exploratory mechanistic study.

Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.

Intervention: One group receives maraviroc (dose dependent on co-medication), the other group placebo.

Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group (compared with placebo).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

  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 venepuncture for immunologic and virologic investigations (see flow chart).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: maraviroc
    maraviroc dose dependent on co-medication
    Other Names:
    • Celsentri
    • Celsentry
  • Drug: Placebo
    Placebo drug
Study Arms  ICMJE
  • Active Comparator: Maraviroc
    Intervention: Drug: maraviroc
  • Placebo Comparator: Placebo
    Placebo drug
    Intervention: Drug: Placebo
Publications * van Lelyveld SF, Drylewicz J, Krikke M, Veel EM, Otto SA, Richter C, Soetekouw R, Prins JM, Brinkman K, Mulder JW, Kroon F, Middel A, Symons J, Wensing AM, Nijhuis M, Borghans JA, Tesselaar K, Hoepelman AI; MIRS study group. Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial. PLoS One. 2015 Jul 24;10(7):e0132430. doi: 10.1371/journal.pone.0132430. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2013)
85
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2009)
130
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00875368
Other Study ID Numbers  ICMJE 08-283
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party S.F.L. van Lelyveld, UMC Utrecht
Study Sponsor  ICMJE S.F.L. van Lelyveld
Collaborators  ICMJE
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Erasmus Medical Center
  • Leiden University Medical Center
  • Onze Lieve Vrouwe Gasthuis
  • Slotervaart Hospital
  • Rijnstate Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator:Andy IM Hoepelman, MD, PhDUMC Utrecht
PRS Account UMC Utrecht
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP