Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy

NCT02611895 | Completed

• 1 other identifier: 9503
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1 Infection

Keywords

Aviremic HIV-1 infected patients; HAART; Integrase inhibitor Raltegravir; Ongoing HIV infection

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

• Causes and consequences of persistent de novo infection in virologic responders to HAART

  1 day

Study Arms (1)

HIV DNA

EXPERIMENTAL

Blood test : Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells

Biological: HIV DNA

Interventions

HIV DNA BIOLOGICAL

Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells

HIV DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years
• HIV-1 infection
• Efficient and well tolerated antiretroviral treatment for more than 12 months
• 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

You may not qualify if:

• Patient is pregnant or breastfeeding

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institute of Human Genetics, France: collaborator

Study Sites (1)

University hospital Montpellier

Montpellier, 34295, France

Location

Study Officials

• CHRISTINA PSOMAS

  University Hospital of Montpellier, Montpellier, France, 34295

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: March 1, 2015
• Primary Completion: March 22, 2016
• Study Completion: December 31, 2016
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

FR (1)