Human Immunodeficiency VirusVIRECTNCT02526940
Impact of Pre-ART Blood CD4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Although combined antiretroviral therapy (cART) has dramatically improved quality of life and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of HIV target cells as activated memory… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- rectal biopsies and Blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Aug 2015
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 3 groups of men elaborated on the basis of their blood CD4+ T cells count at the time of cART initiation: >350; 350-200; <200, respectively.
Who may be able to join
- Seropositive for HIV
- Under HAART since at least one and less than 4 years
- No blood HIV RNA rebound during the therapy
- Indication of Human Papilloma Virus (HPV) screening by anal rectoscopy
- Signature of the informed consent form
Who cannot join
- Patient under tutelage
- No signature of the informed consent form
- No CD4 cell count available at the time of HAART initiation
- One or several viral rebound(s) during therapy
- Coinfection by hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Hemostasis disorders, anticoagulant therapy
Show all 9Show fewer
- No medical indication of rectoscopy
- Inflammatory bowel disease
- No understanding of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre- Antiretroviral Therapy (ART) Blood Cluster of Differentiation (CD)4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men
Although combined antiretroviral therapy (cART) has dramatically improved quality of life and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells. Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could be also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17 secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion could be associated with HIV progression since these cells play a crucial role in the maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of the intestinal epithelial barrier integrity. These damages are responsible for an increase in microbial translocation, which is associated with immune activation and progression to AIDS. Several recent studies have shown that cART initiation during acute or early HIV-1 infection reduces HIV DNA reservoir size and improves immune reconstitution in blood. Post-treatment controllers, who started long-term cART early after HIV infection, have very low levels of HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers. Unlike most HIV-infected individuals, they maintain an undetectable plasmatic viral load after several years of cART interruption, suggesting that a weak reservoir is a prerequisite to achieve a functional cure. By extrapolation, it could be hypothesized that the gut viral reservoir is also decreased and that mucosal immunity is restored when cART is initiated during primary phase of infection. The gut viral reservoir begins to form within the first days after HIV exposure, and grows during acute HIV infection. Similarly, intestinal T cells are depleted very early after infection, due to high viral replication, host immune response and bystander effects. Most studies also concluded that long-term and optimal treatment can't fully restore mucosal immunity. These observations led us to study the impact of time of cART start on the size of viral reservoir and on immune reconstitution in the gut. For this, we analyzed the virological and immunological characteristics of the rectal HIV reservoir of long-term treated patients regarding their blood CD4+ T cells count at the time of cART initiation.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- rectal biopsies, Blood samples
- Keywords
- Human Immunodeficiency Virus, HIV, HAART, Highly Active antiretroviral therapy, GALT, Gut Associated Lymphoid Tissue, reservoir, rectum
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal biopsiesProcedure or surgery
6 rectal biopsies
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| blood CD4 cells count < 200/mm3 | patients with blood CD4 cells count at the time of initiation of HAART< 200/mm3.
Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years Receives: Procedure: rectal biopsies; Other: Blood samples | |
| blood CD4 cells count : 200 - 300/mm3 | patients with blood CD4 cells count at the time of initiation of HAART between 200 and 300/mm3 Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years Receives: Procedure: rectal biopsies; Other: Blood samples | |
| blood CD4 cells count >350/mm3 | patients with blood CD4 cells count at the time of initiation of HAART> 350/mm3.
Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years Receives: Procedure: rectal biopsies; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV DNA load in rectal biopsies
Comparison of HIV DNA load (copies/106 cells) in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of Highly Active Antiretroviral Therapy (HAART) : <200, 200-300 and >350/mm3
Measured: day 1
Secondary outcomes (5)
HIV DNA load in blood peripheral blood mononuclear cell (PBMC)
Comparison of HIV DNA load (copies/106 cells) in blood PBMC between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
Measured: Day 1
HIV RNA load in blood PBMC
Comparison of HIV RNA load (copies/106 cells) in blood PBMC between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
Measured: Day 1
HIV RNA load in rectal biopsies
Comparison of HIV RNA load (copies/106 cells) in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
Measured: Day 1
Cellular composition in rectal biopsies
Comparison of Cellular composition in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3.
Cellular composition is a outcome measure : expression of CD3, CD4, CD8, CD27, CD45, CCR5 by flow cytometry
Measured: Day 1
Cellular composition in blood PBMC
Comparison of Cellular composition in blood PBMCbetween 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3.
Cellular composition is a outcome measure : expression of CD3, CD4, CD8, CD27, CD45, CCR5 by flow cytometry
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic LUCHT, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526940
- Sponsor's protocol ID
- 1308020
- Acronym
- VIRECT
- Status last verified
- Oct 2015
- First submitted
- 17 Aug 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre- Antiretroviral Therapy (ART) Blood Cluster of Differentiation (CD)4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men
- ClinicalTrials.gov ID
- NCT02526940
- Acronym / sponsor ID
- VIRECT / 1308020
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, HIV, HAART, Highly Active antiretroviral therapy, GALT, Gut Associated Lymphoid Tissue, reservoir, rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Aug 2015 (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.
Although combined antiretroviral therapy (cART) has dramatically improved quality of life and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells. Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could be also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17 secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion could be associated with HIV progression since these cells play a crucial role in the maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of the intestinal epithelial barrier integrity. These damages are responsible for an increase in microbial translocation, which is associated with immune activation and progression to AIDS. Several recent studies have shown that cART initiation during acute or early HIV-1 infection reduces HIV DNA reservoir size and improves immune reconstitution in blood. Post-treatment controllers, who started long-term cART early after HIV infection, have very low levels of HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers. Unlike most HIV-infected individuals, they maintain an undetectable plasmatic viral load after several years of cART interruption, suggesting that a weak reservoir is a prerequisite to achieve a functional cure. By extrapolation, it could be hypothesized that the gut viral reservoir is also decreased and that mucosal immunity is restored when cART is initiated during primary phase of infection. The gut viral reservoir begins to form within the first days after HIV exposure, and grows during acute HIV infection. Similarly, intestinal T cells are depleted very early after infection, due to high viral replication, host immune response and bystander effects. Most studies also concluded that long-term and optimal treatment can't fully restore mucosal immunity. These observations led us to study the impact of time of cART start on the size of viral reservoir and on immune reconstitution in the gut. For this, we analyzed the virological and immunological characteristics of the rectal HIV reservoir of long-term treated patients regarding their blood CD4+ T cells count at the time of cART initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| blood CD4 cells count < 200/mm3 | – | Procedure: rectal biopsies, Other: Blood samplespatients with blood CD4 cells count at the time of initiation of HAART< 200/mm3. Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years |
| blood CD4 cells count : 200 - 300/mm3 | – | Procedure: rectal biopsies, Other: Blood samplespatients with blood CD4 cells count at the time of initiation of HAART between 200 and 300/mm3 Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years |
| blood CD4 cells count >350/mm3 | – | Procedure: rectal biopsies, Other: Blood samplespatients with blood CD4 cells count at the time of initiation of HAART> 350/mm3. Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups of men elaborated on the basis of their blood CD4+ T cells count at the time of cART initiation: >350; 350-200; <200, respectively.
Key inclusion criteria (5 listed)
- Seropositive for HIV
- Under HAART since at least one and less than 4 years
- No blood HIV RNA rebound during the therapy
- Indication of Human Papilloma Virus (HPV) screening by anal rectoscopy
- Signature of the informed consent form
Key exclusion criteria (9 listed)
- Patient under tutelage
- No signature of the informed consent form
- No CD4 cell count available at the time of HAART initiation
- One or several viral rebound(s) during therapy
- Coinfection by hepatitis B virus (HBV) or hepatitis C virus (HCV)
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 |
|---|---|---|
| rectal biopsies6 rectal biopsies | Procedure or surgery | blood CD4 cells count : 200 - 300/mm3, blood CD4 cells count < 200/mm3, blood CD4 cells count >350/mm3 |
| Blood samplesBlood samples | Other | blood CD4 cells count : 200 - 300/mm3, blood CD4 cells count < 200/mm3, blood CD4 cells count >350/mm3 |
Primary outcome
HIV DNA load in rectal biopsies
Time frame: day 1
Comparison of HIV DNA load (copies/106 cells) in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of Highly Active Antiretroviral Therapy (HAART) : <200, 200-300 and >350/mm3
5 secondary outcomes
HIV DNA load in blood peripheral blood mononuclear cell (PBMC)
Time frame: Day 1
HIV RNA load in blood PBMC
Time frame: Day 1
HIV RNA load in rectal biopsies
Time frame: Day 1
Cellular composition in rectal biopsies
Time frame: Day 1
Cellular composition in blood PBMC
Time frame: Day 1
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 2 Nov 2015.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Frederic LUCHT, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 9 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 2 Nov 2015. 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?
HIV DNA load in rectal biopsies (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2015.