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

NCT00795444

Last updated date
Study Location
Hospital Universitario Ramon Y Cajal
Madrid, , 28034, Spain
Contact
1-800-718-1021

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE HIV-1
Intervention  ICMJE Drug: maraviroc
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
Other Names:
  • celsentri
  • CCR5 coreceptor antagonist
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795444
Other Study ID Numbers  ICMJE ERRADVIH-01
Eudra CT 2007-003995-21
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Santiago Moreno Guillen, MD,PhDHOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID
PRS Account Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Verification Date January 2015

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