HIV-1 InfectionMUCOVIRNCT01019044
Exploration of HIV Reservoirs
An observational study of HIV-1 Infection, run by Objectif Recherche Vaccins SIDA at 1 site in France.
Trial summary
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Rectal mucosa biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Nov 2009
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 infected patients followed in specialized infectious disease/HIV hospital department
Who may be able to join
- HIV-1 documented infection
- HIV-1 plasma viral load measurable before antiretroviral treatment initiation
- Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation
- Patients with a stable plasma viral load below the limit of detection (HIV-RNA < 50 copies/ml since January 2006 and/or HIV-RNA < 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures
Who cannot join
- Contraindication to the biopsy
- No ability or willingness to provide informed consent
- Concomitant treatment with antithrombotics or platelets antiaggregatory
- Patients co-infected with HCV and or HBV
- Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.
Read the detailed description
Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).
- Conditions
- HIV-1 Infection
- Being tested
- Rectal mucosa biopsy
- Keywords
- HIV, Viral reservoirs, Viral load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal mucosa biopsyProcedure or surgery
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction
| Study group | Role | What they receive |
|---|---|---|
| Rectal mucosa biopsy | Rectal mucosa samples collection Receives: Procedure: Rectal mucosa biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
Measured: Single patient visit
Secondary outcomes (4)
Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs
Measured: Single patient visit
Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies
Measured: Single patient visit
Quantification of HIV proviral DNA in the total CD4 lymphocytes
Measured: Single patient visit
Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood
Measured: Single patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
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-1 InfectionStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Objectif Recherche Vaccins SIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine KATLAMA, MD, Principal investigator, Groupe Hospitalier Pitie-SalpetriereFrançois LECARDONNEL, MSc, Study director, ORVACS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019044
- Sponsor's protocol ID
- ORVACS 009
- Acronym
- MUCOVIR
- Status last verified
- Feb 2013
- First submitted
- 24 Nov 2009
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel F, Katlama C, Autran B, Marcelin AG, Valantin MA, Carcelain G; DECAMUNE and ORVACS Study Groups. Direct quantification of cell-associated HIV DNA in isolated rectal and blood memory CD4 T cells revealed their similar and low infection levels in long-term treated HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.
PubMed 23274932
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
- ClinicalTrials.gov ID
- NCT01019044
- Acronym / sponsor ID
- MUCOVIR / ORVACS 009
- Conditions
- HIV-1 Infection
- Keywords
- HIV, Viral reservoirs, Viral load
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Objectif Recherche Vaccins SIDAUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Nov 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.
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.
Detailed description
Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal mucosa biopsy | – | Procedure: Rectal mucosa biopsyRectal mucosa samples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected patients followed in specialized infectious disease/HIV hospital department
Key inclusion criteria (4 listed)
- HIV-1 documented infection
- HIV-1 plasma viral load measurable before antiretroviral treatment initiation
- Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation
- Patients with a stable plasma viral load below the limit of detection (HIV-RNA < 50 copies/ml since January 2006 and/or HIV-RNA < 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures
Key exclusion criteria (5 listed)
- Contraindication to the biopsy
- No ability or willingness to provide informed consent
- Concomitant treatment with antithrombotics or platelets antiaggregatory
- Patients co-infected with HCV and or HBV
- Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)
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 mucosa biopsyCollection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction | Procedure or surgery | Rectal mucosa biopsy |
Primary outcome
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
Time frame: Single patient visit
4 secondary outcomes
Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs
Time frame: Single patient visit
Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies
Time frame: Single patient visit
Quantification of HIV proviral DNA in the total CD4 lymphocytes
Time frame: Single patient visit
Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood
Time frame: Single patient visit
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 13 Feb 2013.
- Results publication: PubMed 23274932Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel F, Katlama C, Autran B, Marcelin AG, Valantin MA, Carcelain G; DECAMUNE and ORVACS Study Groups. Direct quantification of cell-associated HIV DNA in isolated rectal and blood memory CD4 T cells revealed their similar and low infection levels in long-term treated HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.
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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.
Christine KATLAMA, MD principal investigator
Groupe Hospitalier Pitie-Salpetriere
François LECARDONNEL, MSc study director
ORVACS
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 HIV-1 Infection, run by Objectif Recherche Vaccins SIDA 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 4 inclusion and 5 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 13 Feb 2013. 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?
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) (time frame: Single patient visit). 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 NCT01019044, 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 13 Feb 2013.