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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00795444
First received: November 10, 2008
Last updated: January 31, 2013
Last verified: January 2013

November 10, 2008
January 31, 2013
March 2008
September 2013   (final data collection date for primary outcome measure)
Frequency of resting CD4+ T cells infected by a replicative virus [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Frequency of resting CD4+ T cells infected by a replicative virus [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795444 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV-1
Drug: maraviroc
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
Other Names:
  • maraviroc
  • celsentri
  • CCR5 coreceptor antagonist
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.
Intervention: Drug: maraviroc

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00795444
ERRADVIH-01, Eudra CT 2007-003995-21
No
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Pfizer
Principal Investigator: Santiago Moreno Guillen, MD,PhD HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
January 2013

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