Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1

January 23, 2015 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Pilot Study Of The Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.

Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir.

If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).

The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
  • Aged over 18 years.
  • Chronic HIV infection
  • Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
  • Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA/mL) for at least 2 years.
  • CD4+ T lymphocyte count above 350 cells/mm3.
  • Demonstration of R5 viral tropism (use of CCR5 coreceptors) by phenotyping in plasma samples stored before antiretroviral therapy is started.
  • Understand the objective of the study and be available to make frequent visits to the hospital.

Exclusion Criteria:

  • Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
  • Proven resistance against the antiretroviral drugs under study.
  • Planned interruption of antiretroviral therapy.
  • Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
  • Taking a fusion inhibitor (enfuvirtide).
  • Pregnancy or intention to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maraviroc
Adult patients with HIV infection and a viral load that has been suppressed for a long period (less than 50 copies/mL for at least 2 years) while on antiretroviral therapy.The treatment group will maintain the habitual antiretroviral therapy combined with maraviroc.
Drug: maraviroc
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
Other Names:
  • celsentri
  • CCR5 coreceptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of resting CD4+ T cells infected by a replicative virus
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Pfizer

Investigators

  • Principal Investigator: Santiago Moreno Guillen, MD,PhD, Hospital Universitario Ramón y Cajal. Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERRADVIH-01
  • Eudra CT 2007-003995-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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