A Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by St Stephens Aids Trust
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01680536
First received: September 4, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many people successfully take only darunavir/ritonavir treatment for their HIV. However, there are some concerns that this treatment may not reach some areas of the body, such as the brain and spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.

There is already a large clinical study looking at any differences between 'conventional' HIV treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the CNS. However, this study will only be finished in 2013.

The investigators know that maraviroc can reach the CNS very effectively. The investigators in this study will investigate the effect of adding maraviroc to darunavir/ritonavir monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS, called cerebrospinal fluid or CSF.

Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2 clinical studies when it was taken by people whose HIV virus had developed resistance to previous HIV treatments.

This study will also investigate safety as well as monitor effectiveness when patients take maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.

Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain function. Therefore this study will also investigate brain (neurocognitive) functioning with a computer test and some written tests.


Condition Intervention Phase
HIV
Drug: maraviroc
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Changes in inflammatory markers in CSF week 12 to week 36 [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    To investigate changes from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks


Secondary Outcome Measures:
  • CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To investigate changes in CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc, darunavir, ritonavir
Single-arm,assessing cerebrospinal fluid inflammatory markers after addition of maraviroc to patients stable on monotherapy darunavir/ritonavir
Drug: maraviroc

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient volunteers who meet all of the following criteria are eligible for this trial:

  1. male or female aged between 18 and 65 years
  2. has a documented HIV-1 infection
  3. has signed the Informed Consent Form voluntarily
  4. is willing to comply with the protocol requirements
  5. has an HIV-plasma viral load at screening <40 copies/mL (one off retesting for blips <200 copies/ml is allowed)
  6. has a CD4 cell count at Screening >200 cells/mm3
  7. has been on a stable darunavir/ritonavir regimen 800/100 once daily alone for at least 12 weeks at Screening, and willing to remain on this;
  8. estimated glomerular filtration rate (by MDRD or CG methods) >60 ml/min at screening
  9. CCR5 tropic by geno2pheno assay performed at screening
  10. if female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs); Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
  11. if a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit

Exclusion Criteria:

Patients meeting 1 or more of the following criteria cannot be selected:

  1. is infected with HIV-2
  2. is using any concomitant therapy disallowed as per SPC for the study drugs (section 5.2)
  3. has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions (must be discussed with the Investigator prior to enrolment):Stable cutaneous Kaposi's Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
  4. has acute viral hepatitis including, but not limited to, A, B, or C
  5. has chronic hepatitis B and/or C
  6. has received any investigational drug within 30 days prior to the trial drug administration
  7. Clinically significant allergy or hypersensitivity to any trial medication excipients
  8. If female, she is pregnant or breastfeeding
  9. Screening blood results with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
  10. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN.
  11. Platelets of < 50 based on lumbar puncture examination at baseline.
  12. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680536

Contacts
Contact: Prof Brian Gazzard 020 8746 5601 Yvonne.Stupple@chelwest.nhs.uk

Locations
United Kingdom
St Stephen's AIDS Trust Recruiting
London, United Kingdom, SW10 9TH
Principal Investigator: Prof Brian Gazzard         
Sponsors and Collaborators
St Stephens Aids Trust
  More Information

No publications provided

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01680536     History of Changes
Other Study ID Numbers: SSAT 046
Study First Received: September 4, 2012
Last Updated: January 16, 2013
Health Authority: England: NRES Committee London - South East
England: MHRA

Additional relevant MeSH terms:
Darunavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014