HIV InfectionEP 44NCT01038401
Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study
A study testing GI endoscopy and GALT biopsies and A sample of venous blood will also be collected in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- GI endoscopy and GALT biopsies and A sample of venous blood will also be collected
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study
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.
Read the detailed description
Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.
- Conditions
- HIV Infection
- Being tested
- GI endoscopy and GALT biopsies, A sample of venous blood will also be collected
- Keywords
- HIV infection, HAART, Viral DNA test positive-10063306, Blood HIV RNA 10049826, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI endoscopy and GALT biopsiesProcedure or surgery
This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
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
| Study group | Role | What they receive |
|---|---|---|
| HIV-1-infected patients on effective HAART | Other | Not described Receives: Procedure: GI endoscopy and GALT biopsies; Biological: A sample of venous blood will also be collected |
| Non Infected HIV Volunteers | Other | Not described Receives: Procedure: GI endoscopy and GALT biopsies; Biological: A sample of venous blood will also be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MASSIP Patrice, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038401
- Sponsor's protocol ID
- 2008-A00239-46
- Acronym
- EP 44
- Status last verified
- Jul 2010
- First submitted
- 22 Dec 2009
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22156200
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study
- ClinicalTrials.gov ID
- NCT01038401
- Acronym / sponsor ID
- EP 44 / 2008-A00239-46
- Conditions
- HIV Infection
- Keywords
- HIV infection, HAART, Viral DNA test positive-10063306, Blood HIV RNA 10049826, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-1-infected patients on effective HAART | Other | Procedure: GI endoscopy and GALT biopsies, Biological: A sample of venous blood will also be collected |
| Non Infected HIV Volunteers | Other | Procedure: GI endoscopy and GALT biopsies, Biological: A sample of venous blood will also be collected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI endoscopy and GALT biopsiesThis project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT) | Procedure or surgery | HIV-1-infected patients on effective HAART, Non Infected HIV Volunteers |
| A sample of venous blood will also be collectedThese samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT | Biological | HIV-1-infected patients on effective HAART, Non Infected HIV Volunteers |
Primary outcome
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 22156200Mavigner 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MASSIP Patrice principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI endoscopy and GALT biopsies and A sample of venous blood will also be collected in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.