Safety and Effectiveness of Addition of Maraviroc to ART Regimens in HIV-Infected Adults With Suboptimal CD4 T-Cell Count Recovery Despite Sustained Virologic Suppression - Tabular View

Tracking Information

First Received Date ^ICMJE

July 1, 2008

Last Updated Date

February 19, 2009

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Increase in CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00709111 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Persistence of CD4 count increase after discontinuation of MVC [ Time Frame: From Weeks 24 to 48 ] [ Designated as safety issue: No ]
Safety and tolerability of MVC in subjects on ART with suboptimal CD4 response [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Mechanism by which MVC influences CD4 count measured by a set of immunologic markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Effect of MVC on gut microbial translocation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Effect of MVC on low-level HIV-1 viremia [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Effect of MVC on inflammatory markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Adherence to study medications and relationship between adherence and study outcome [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Effectiveness of Addition of Maraviroc to ART Regimens in HIV-Infected Adults With Suboptimal CD4 T-Cell Count Recovery Despite Sustained Virologic Suppression

Official Title ^ICMJE

A Pilot Trial of Maraviroc for Treatment of Subjects on Antiretroviral Therapy With Suboptimal CD4 T-Cell Count Recovery Despite Sustained Virologic Suppression

Brief Summary

Some HIV-infected individuals with low viral load on antiretroviral therapy (ART) do not have increased CD4 counts and remains at risk for clinical progression of HIV. The purpose of this study is to assess whether adding maraviroc (MVC) to a stable ART regimen will result in an improved immune response in individuals with a limited CD4 response despite sustained virologic suppression.

Detailed Description

The majority of HIV-infected individuals with virologic suppression on antiretroviral therapy (ART) have a significant increase in CD4 count over the first year. However, a portion of these individuals show a suboptimal immune response and remain at an elevated risk for clinical progression. The primary purpose of this study is to determine the effectiveness and safety of the addition of maraviroc (MVC) to stable treatment regimens in individuals with suboptimal immune response despite sustained virologic suppression.

This study will last approximately 48 weeks. All participants will add MVC to their current antiretroviral drug regimen for 24 weeks. Dosage of MVC will depend on the regimen of each participant. At Week 24, participants will discontinue MVC and be followed for an additional 24 weeks.

All participants will have study visits at study entry and Weeks 4, 8, 12, 16, 22, 24, 36, 46, and 48. A clinical assessment and blood collection will occur at all visits. A questionnaire will take place at select visits. For women, a pregnancy test will occur at study entry and Week 24. MVC will be distributed at study entry and Weeks 8 and 16. Other ART will not be supplied by the study.

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Maraviroc

Study Arms / Comparison Groups

Experimental: Maraviroc (MVC) will be taken orally twice daily for 24 weeks. Dosage is dependent on the pharmacokinetic interaction with participant's current ART and non-ART drug regimen.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV-1 infection
Taking 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
CD4 count less than 250 within 60 days prior to study entry
Stable CD4 count for at least 48 weeks prior to study entry. More information on this criterion can be found in the protocol.
Documentation of CD4 count obtained within 14 days prior to study entry
Documentation of viral load less than the limit of detection. All viral load measurements within 48 weeks of study entry must be less than the limit of detection. More information on this criterion can be found in the protocol.
Confirmation of the availability of stored plasma sample obtained at the pre-entry visit
Confirmation that advanced lymphocyte flow cytometry has been performed within14 days prior to study entry
Females of reproductive potential. More information on this criterion can be found in the protocol.
Agree to use at least two forms of contraception while using study treatment and for the 6 weeks after stopping study treatment

Exclusion Criteria:

Unstable clinical condition. More information on this criterion can be found in the protocol.
Using immunomodulators within 12 months prior to study entry. More information on this criterion can be found in the protocol.
Acute AIDS-defining illness within 60 days prior to study entry
Known allergy/sensitivity or hypersensitivity to 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 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 counts within 6 months prior to study entry
Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Pregnant or breastfeeding

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00709111

Responsible Party

Rona Siskind, DAIDS

Study ID Numbers ^ICMJE

ACTG A5256, A5256

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Adult AIDS Clinical Trials Group

Investigators ^ICMJE

Study Chair:	Timothy J. Wilkin, MD, MPH	Cornell Clinical Research Site
Study Chair:	Roy Gulick, MD, MPH	Cornell HIV Clinical Trials Unit

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

February 2009

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