NCT01038401

Brief Summary

HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 23, 2026

Status Verified

July 1, 2010

Enrollment Period

1.7 years

First QC Date

December 22, 2009

Last Update Submit

April 21, 2026

Conditions

HIV Infection

Keywords

HIV infectionHAARTViral DNA test positive-10063306Blood HIV RNA 10049826Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.

Secondary Outcomes (4)

  • HIV-1 DNA load in the GALT vs blood CD4+ T cells

  • HIV-1 tropism in the GALT vs blood CD4+ T cells

  • Characterization of residual HIV-1 in the plasma < 40 copies/ml

  • Characterization of HIV-1 DNA in blood monocytes

Study Arms (2)

HIV-1-infected patients on effective HAART

OTHER
Procedure: GI endoscopy and GALT biopsiesBiological: A sample of venous blood will also be collected

Non Infected HIV Volunteers

OTHER
Procedure: GI endoscopy and GALT biopsiesBiological: A sample of venous blood will also be collected

Interventions

GI endoscopy and GALT biopsiesPROCEDURE

This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)

HIV-1-infected patients on effective HAARTNon Infected HIV Volunteers
A sample of venous blood will also be collectedBIOLOGICAL

These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT

HIV-1-infected patients on effective HAARTNon Infected HIV Volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infection (ELISA and western-blot tests)
  • Continuous antiretroviral therapy \>= 12 months
  • Plasma HIV-1 RNA =\< 40 copies/ml \>= 6 months
  • Indication of gastro-intestinal endoscopy
  • Age \>= 18-year old
  • Physical examination
  • Informed consent

You may not qualify if:

  • Plasma HIV-1 RNA \> 40 copies/ml in the last 6 months
  • Involvement in a HIV vaccine study
  • Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
  • Treatment with interleukin-2 in the last 6 months
  • Decompensated cirrhosis
  • Abnormal hemostasis tests
  • Inflammatory bowel disease ; coeliac disease
  • Lymphoma
  • Blood transfusion in the last 6 months
  • Absence of social security (health insurance)
  • Pregnant or breastfeeding woman
  • Incapable adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ANRS center from Toulouse

Toulouse, France

Location

Related Publications (1)

  • Mavigner M, Cazabat M, Dubois M, L'Faqihi FE, Requena M, Pasquier C, Klopp P, Amar J, Alric L, Barange K, Vinel JP, Marchou B, Massip P, Izopet J, Delobel P. Altered CD4+ T cell homing to the gut impairs mucosal immune reconstitution in treated HIV-infected individuals. J Clin Invest. 2012 Jan;122(1):62-9. doi: 10.1172/JCI59011. Epub 2011 Dec 12.

    PMID: 22156200RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • MASSIP Patrice

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 23, 2026

Record last verified: 2010-07

Locations

FR(1)