NCT00709111

Brief Summary

Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 24, 2012

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

July 1, 2008

Results QC Date

July 26, 2011

Last Update Submit

September 11, 2018

Conditions

HIV Infections

Keywords

CCR5 antagonistCD4 T-cell countimmune activationtreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Change in CD4+ T-cell Count

    Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).

    From baseline to week 24

Secondary Outcomes (34)

  • Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count

    From baseline to week 24

  • Within-subject CD4+ T-cell Count Slopes

    From baseline through week 24

  • Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24

    From pre-treatment through week 24

  • Change in CD4+ T-cell Count

    From week 24 to week 36

  • Change in CD4+ T-cell Count

    From week 24 to week 48

  • +29 more secondary outcomes

Study Arms (1)

Maraviroc

EXPERIMENTAL

Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.

Drug: Maraviroc

Interventions

MaravirocDRUG

The maraviroc doses were 150 mg orally twice daily, 300 mg orally twice daily, or 600 mg orally twice daily, depending on the pharmacokinetic interaction with a subject's pre-study ART and non-ART drug regimen according to the package insert.

Also known as: MVC, Selzentry
Maraviroc

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infection
  • On ART for at least 48 weeks prior to study entry with a regimen that includes three or more antiretroviral medications
  • No change in ART regimen for at least 24 weeks prior to study entry
  • Screening CD4+ T-cell count less than 250 obtained within 60 days prior to study entry
  • Stable CD4+ T-cell count for at least 48 weeks prior to study entry (as assessed by an estimated CD4+ T-cell count slope between -20 and +20 cells/year)
  • Screening HIV-1 RNA below the limit of detection using an FDA-approved assay obtained within 60 days prior to study entry
  • All other plasma HIV-1 RNA measurements in the 48 weeks prior to study entry must be below the limit of detection
  • Laboratory values obtained within 60 days prior to study entry:
  • Absolute neutrophil count (ANC) \>=750/µL
  • Hemoglobin \>=9.0 g/dL for female subjects and \>=10.0 g/dL for male subjects
  • Platelet count \>=50,000/ µL
  • Calculated creatinine clearance (CrCl) \>=30 mL/min
  • Aspartate aminotransferase (serum glutamic oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), and alkaline phosphatase \<=5 X Upper Limit of Normal (ULN)
  • Direct bilirubin \<=2.5 X ULN
  • Females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to study entry
  • +1 more criteria

You may not qualify if:

  • Unstable clinical condition
  • Currently breast-feeding or pregnant
  • Use of immunomodulators or cancer chemotherapy or radiation treatment within 12 months prior to study entry
  • An acute AIDS-defining illness within 60 days prior to study entry
  • Known allergy/sensitivity or hypersensitivity to components of MVC, including allergy or hypersensitivity to soya lecithin, soya or peanuts
  • Active drug or alcohol abuse that, in the opinion of the investigator, would interfere with adherence to study regimens
  • Serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry
  • Receipt of a vaccine within 30 days prior to study entry
  • Current or previous use of a CCR5 inhibitor
  • Plan to change background ART regimen within 24 weeks after study entry
  • Receipt of experimental or non-experimental medications for the purpose of raising CD4+ T-cell counts within 6 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Alabama Therapeutics CRS (5801)

Birmingham, Alabama, 35294, United States

Location

UCLA CARE Center CRS (601)

Los Angeles, California, 90035, United States

Location

Stanford CRS (501)

Palo Alto, California, 94304, United States

Location

Ucsd, Avrc Crs (701)

San Diego, California, 92103, United States

Location

Ucsf Aids Crs (801)

San Francisco, California, 94110, United States

Location

Georgetown University CRS (GU CRS) (1008)

Washington D.C., District of Columbia, 20007, United States

Location

Univ. of Miami AIDS CRS (901)

Miami, Florida, 33136, United States

Location

The Ponce de Leon Ctr. CRS (5802)

Atlanta, Georgia, 30308, United States

Location

Northwestern University CRS (2701)

Chicago, Illinois, 60611, United States

Location

IHV Baltimore Treatment CRS (4651)

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Adult AIDS CRS (201)

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital ACTG CRS (101)

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hosp. ACTG CRS (107)

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center ACTG CRS (104)

Boston, Massachusetts, 02118, United States

Location

Washington University CRS (2101)

St Louis, Missouri, 63110, United States

Location

Cornell CRS (7804)

New York, New York, 10011, United States

Location

NY Univ. HIV/AIDS CRS (401)

New York, New York, 10016, United States

Location

AIDS Care CRS (1108)

Rochester, New York, 14642, United States

Location

Univ. of Rochester ACTG CRS (1101)

Rochester, New York, 14642, United States

Location

Unc Aids Crs (3201)

Chapel Hill, North Carolina, 27516, United States

Location

Duke Univ. Med. Ctr. Adult CRS (1601)

Durham, North Carolina, 27710, United States

Location

Univ. of Cincinnati CRS (2401)

Cincinnati, Ohio, 45267, United States

Location

MetroHealth CRS (2503)

Cleveland, Ohio, 44109, United States

Location

The Ohio State Univ. AIDS CRS (2301)

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS (6201)

Philadelphia, Pennsylvania, 19104, United States

Location

Pittsburgh CRS (1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Therapeutics CRS (3652)

Nashville, Tennessee, 37204, United States

Location

Peabody Health Ctr. CRS (31443)

Dallas, Texas, 75215, United States

Location

Houston AIDS Research Team CRS (31473)

Houston, Texas, 77030, United States

Location

Related Publications (6)

  • Fadel H, Temesgen Z. Maraviroc. Drugs Today (Barc). 2007 Nov;43(11):749-58. doi: 10.1358/dot.2007.43.11.1131763.

    PMID: 18174962BACKGROUND

  • MacArthur RD, Novak RM. Reviews of anti-infective agents: maraviroc: the first of a new class of antiretroviral agents. Clin Infect Dis. 2008 Jul 15;47(2):236-41. doi: 10.1086/589289.

    PMID: 18532888BACKGROUND

  • Wilkin T, Lalama C, Tenorio A, Landay A, Ribaudo H, McKinnon J, Gandhi R, Mellors J, Currier J, and Gulick R. Maraviroc Intensification for Suboptimal CD4+ Cell Response Despite Sustained Virologic Suppression: ACTG 5256. 17th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, February 16-19, 2010.

    RESULT

  • Wilkin T, Lalama C, Tenorio A, Landay A, Fox L, McKinnon J, Gandhi R, Mellors J, Currier J, Gulick R. ACTG 5256: Effect of adding and removing maraviroc (MVC) on immune activation in participants on suppressive antiretroviral therapy (ART). 18th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 27-March 02, 2011.

    RESULT

  • Hilldorfer B, Lalama C, McKinnon J, Coombs B, Tenorio A, Fox L, Gandhi R, Ribaudo H, Currier J, Gulick R, Wilkin TJ, Mellors J. Effects of Maraviroc (MVC) on Residual Low-Level Viremia in Patients on Suppressive Antiretroviral Therapy (ART): Results from ACTG 5256. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, July 17-20, 2011.

    RESULT

  • Wilkin TJ, Lalama CM, McKinnon J, Gandhi RT, Lin N, Landay A, Ribaudo H, Fox L, Currier JS, Mellors JW, Gulick R, Tenorio AR. A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4(+) T-cell recovery despite sustained virologic suppression: ACTG A5256. J Infect Dis. 2012 Aug 15;206(4):534-42. doi: 10.1093/infdis/jis376. Epub 2012 Jun 27.

    PMID: 22740718DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
ACTG ClinicalTrials.gov Coordinator
Organization
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
ACTGCT.Gov@s-3.com
(301) 628-3313

Study Officials

  • Timothy J. Wilkin, MD, MPH

    Cornell Clinical Research Site

    STUDY CHAIR

  • Roy Gulick, MD, MPH

    Cornell HIV Clinical Trials Unit

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

October 12, 2018

Results First Posted

February 24, 2012

Record last verified: 2018-09

Locations

US(29)