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Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

Primary Purpose

HIV-1, HIV Infections

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Raltegravir

About this trial

This is an interventional basic science trial for HIV-1 focused on measuring HIV-1, integrase inhibitor (raltegravir), the cell reservoir of HIV-1, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.

Sites / Locations

Hospital Universitario Ramon Y Cajal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltegravir

Arm Description

Outcomes

Primary Outcome Measures

To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART

Secondary Outcome Measures

Full Information

NCT ID

NCT00807443

First Posted

December 11, 2008

Last Updated

January 31, 2013

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00807443

Brief Title

Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

Official Title

Pilot Study Of The Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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 an integrase inhibitor 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 an integrase inhibitor 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1, HIV Infections

Keywords

HIV-1, integrase inhibitor (raltegravir), the cell reservoir of HIV-1, treatment experienced

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Raltegravir

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Intervention Description

Raltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp & Dohme. A dose of 400 mg will be administered every 12 hours

Primary Outcome Measure Information:

Title

To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Santiago Moreno Guillen, MD,PhD

Organizational Affiliation

HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Ramon Y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23046968

Citation

Serrano-Villar S, Gutierrez C, Vallejo A, Hernandez-Novoa B, Diaz L, Abad Fernandez M, Madrid N, Dronda F, Zamora J, Munoz-Fernandez MA, Moreno S. The CD4/CD8 ratio in HIV-infected subjects is independently associated with T-cell activation despite long-term viral suppression. J Infect. 2013 Jan;66(1):57-66. doi: 10.1016/j.jinf.2012.09.013. Epub 2012 Oct 6.

Results Reference

derived

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Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

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