Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy (RALNOVO)
Primary Purpose
HIV-1 Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HIV DNA
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV-1 Infection focused on measuring Aviremic HIV-1 infected patients, HAART, Integrase inhibitor Raltegravir, Ongoing HIV infection
Eligibility Criteria
Inclusion Criteria:
- Age > or = 18 years
- HIV-1 infection
- Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion
- Efficient and well tolerated antiretroviral treatment for more than 12 months
- HIV-1 viral load < 50 copies/ml for more than 12 months before inclusion
- Patient able to understand the nature, the objective and the methods of the study
- Patient having signed the informed consent
- Affiliation to French Social Security System
Exclusion Criteria:
- Patient is currently participating or has participated in a study (within the exclusion period defined by this study)
- Patient is pregnant or breastfeeding
Sites / Locations
- University hospital Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIV DNA
Arm Description
Blood test : Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells
Outcomes
Primary Outcome Measures
Frequency of virologic responders harbouring intracytoplasmic HIV DNA in their peripheral blood CD4+ T cells, used as a surrogate marker of ongoing HIV infection, between subjects whose regimen contains or not the integrase inhibitor raltegravir.
Frequency of virologic responders harbouring intracytoplasmic HIV DNA in their peripheral blood CD4+ T cells, used as a surrogate marker of ongoing HIV infection, between subjects whose regimen contains or not the integrase inhibitor raltegravir.
Secondary Outcome Measures
Causes and consequences of persistent de novo infection in virologic responders to HAART
Causes and consequences of persistent de novo infection in virologic responders to HAART
Full Information
NCT ID
NCT02611895
First Posted
November 19, 2015
Last Updated
July 5, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Institute of Human Genetics, France
1. Study Identification
Unique Protocol Identification Number
NCT02611895
Brief Title
Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy
Acronym
RALNOVO
Official Title
Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy ( RALNOVO )
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 22, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Institute of Human Genetics, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients.
Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir.
Secondary objectives
To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood
Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART
Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels
Identify virological responders may benefit from treatment intensification
Detailed Description
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients.
Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir.
Secondary objectives
To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood
Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART
Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels
Identify virological responders may benefit from treatment intensification Methods : HIV patients will be recruited by the doctors of Infectious and Tropical Diseases Service (MIT) in the Montpellier University Hospital.
As part of this research, three additional blood tubes (7 ml EDTA tube) will be collected, totaling 21 ml at the time of blood sampling carried out during two consultations scheduled as part of the usual care the pathology of HIV patients in the Service of MIT.
These consultations will be conducted at baseline and a further 3 to 6 months from the date of inclusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection
Keywords
Aviremic HIV-1 infected patients, HAART, Integrase inhibitor Raltegravir, Ongoing HIV infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIV DNA
Arm Type
Experimental
Arm Description
Blood test : Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells
Intervention Type
Biological
Intervention Name(s)
HIV DNA
Intervention Description
Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells
Primary Outcome Measure Information:
Title
Frequency of virologic responders harbouring intracytoplasmic HIV DNA in their peripheral blood CD4+ T cells, used as a surrogate marker of ongoing HIV infection, between subjects whose regimen contains or not the integrase inhibitor raltegravir.
Description
Frequency of virologic responders harbouring intracytoplasmic HIV DNA in their peripheral blood CD4+ T cells, used as a surrogate marker of ongoing HIV infection, between subjects whose regimen contains or not the integrase inhibitor raltegravir.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Causes and consequences of persistent de novo infection in virologic responders to HAART
Description
Causes and consequences of persistent de novo infection in virologic responders to HAART
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years
HIV-1 infection
Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion
Efficient and well tolerated antiretroviral treatment for more than 12 months
HIV-1 viral load < 50 copies/ml for more than 12 months before inclusion
Patient able to understand the nature, the objective and the methods of the study
Patient having signed the informed consent
Affiliation to French Social Security System
Exclusion Criteria:
Patient is currently participating or has participated in a study (within the exclusion period defined by this study)
Patient is pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHRISTINA PSOMAS
Organizational Affiliation
University Hospital of Montpellier, Montpellier, France, 34295
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy
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