HIV-1-infectionRESERVIH32NCT03940521
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
An observational study of HIV-1-infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load. 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?
- Bioclinical evaluation
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2020to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with aviremic HIV-1 undergoing antiretroviral treatment for at least 2 years. Patients will be divided into 3 groups according to pre-therapeutic CD4+ T cell levels: * "Low" (n=16): < 200 CD4+ T cells/mm3, * "Medium" (n=16): 200 to 500 CD4+ T cells/mm3, * "High" (n=16): >500 CD4+ T cells/mm3.
Who may be able to join
- Patient infected with aviremic HIV-1 (<20 copies of HIV-1 RNA/ml plasma) undergoing antiretroviral treatment for at least 2 years
- Patient has known duration of infection and treatment
- Patient has known pretherapeutic CD4+ T cell count and viremia
- Patient has known CD4+ T cell count, residual viremia and CD4/CD8 ratio for previous 2 years
- Patient weighs at least 56kg
- The patient is not opposed to their inclusion in the study
- The patient must be a member or beneficiary of a health insurance plan
- Patient at least 18 years old
Who cannot join
- Patient has an acute infection
- The subject has already been included in the study or is in a period of exclusion determined by a previous study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.
- Conditions
- HIV-1-infection
- Being tested
- Bioclinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioclinical evaluationOther
50-100ml blood extracted for flow cytometry and qPCR
| Study group | Role | What they receive |
|---|---|---|
| HIV-A infected patients | Not described Receives: Other: Bioclinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CD4+ T cells expressing CD32 alone
%
Measured: Day 0
Percentage of CD4+ T cells expressing X alone
%
Measured: Day 0
Percentage of CD4+ T cells expressing both CD32 and X
%
Measured: Day 0
Quantification of proviral load
Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells
Measured: Day 0
Secondary outcomes (19)
Duration of infection prior to treatment
Months
Measured: Day 0
Duration of treatment
Months
Measured: Day 0
Year treatment commenced
Year
Measured: Day 0
Pre-therapeutic CD4 + T cell count
Number of CD4+ T cells/ microL blood
Measured: Day 0
Pre-therapeutic viremia
Number of copies of HIV-1 RNA/ml plasma
Measured: Day 0
Change in CD4+ T cells over previous 2 years
Number of CD4+ T cells/microL blood lost per year
Measured: Day 0
Change in CD4+ T cells prior to treatment
Number of CD4+ T cells/microL blood lost per year
Measured: Day 0
Change in CD4+ T cells during treatment
Number of CD4+ T cells/microL blood lost per year
Measured: Day 0
Viremia at inclusion into the study
Number of copies of HIV-1 RNA/ml plasma
Measured: Day 0
Viremia during the 2 previous years
Number of copies of HIV-1 RNA/ml plasma
Measured: Day 0
Residual immune activation at inclusion into the study
CD4/CD8 ratio
Measured: Day 0
Residual immune activation during the previous 2 years
CD4/CD8 ratio
Measured: Day 0
Nature of current treatment
Family of molecule
Measured: Day 0
Co-infection with hepatitis C virus
Yes/No
Measured: Day 0
Co-infection with hepatitis B virus
Yes/No
Measured: Day 0
Co-infection with Cytomegalovirus
Yes/No
Measured: Day 0
Co-infection with Epstein-Barr virus
Yes/No
Measured: Day 0
Testing for intact proviral DNA
Number of copies/million cells
Measured: Day 0
Circulating viral RNA sequence
RNA sequence
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start30 Sep 2020
- Primary completion30 Sep 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Génétique Moléculaire de Montpellier
- Responsible party
- Sponsor
- Investigators
- Pierre Corbeau, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940521
- Sponsor's protocol ID
- NIMAO/2018-02/PC-01
- Acronym
- RESERVIH32
- Status last verified
- Nov 2025
- First submitted
- 6 May 2019
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
- ClinicalTrials.gov ID
- NCT03940521
- Acronym / sponsor ID
- RESERVIH32 / NIMAO/2018-02/PC-01
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Institut de Génétique Moléculaire de Montpellier
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 May 2019 (actual)
- 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.
The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-A infected patients | – | Other: Bioclinical evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aviremic HIV-1 undergoing antiretroviral treatment for at least 2 years. Patients will be divided into 3 groups according to pre-therapeutic CD4+ T cell levels: * "Low" (n=16): < 200 CD4+ T cells/mm3, * "Medium" (n=16): 200 to 500 CD4+ T cells/mm3, * "High" (n=16): >500 CD4+ T cells/mm3.
Key inclusion criteria (8 listed)
- Patient infected with aviremic HIV-1 (<20 copies of HIV-1 RNA/ml plasma) undergoing antiretroviral treatment for at least 2 years
- Patient has known duration of infection and treatment
- Patient has known pretherapeutic CD4+ T cell count and viremia
- Patient has known CD4+ T cell count, residual viremia and CD4/CD8 ratio for previous 2 years
- Patient weighs at least 56kg
Key exclusion criteria (5 listed)
- Patient has an acute infection
- The subject has already been included in the study or is in a period of exclusion determined by a previous study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
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 |
|---|---|---|
| Bioclinical evaluation50-100ml blood extracted for flow cytometry and qPCR | Other | HIV-A infected patients |
Primary outcome
Percentage of CD4+ T cells expressing CD32 alone
Time frame: Day 0
%
Percentage of CD4+ T cells expressing X alone
Time frame: Day 0
%
Percentage of CD4+ T cells expressing both CD32 and X
Time frame: Day 0
%
Quantification of proviral load
Time frame: Day 0
Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells
19 secondary outcomes
Duration of infection prior to treatment
Time frame: Day 0
Duration of treatment
Time frame: Day 0
Year treatment commenced
Time frame: Day 0
Pre-therapeutic CD4 + T cell count
Time frame: Day 0
Pre-therapeutic viremia
Time frame: Day 0
Change in CD4+ T cells over previous 2 years
Time frame: Day 0
Change in CD4+ T cells prior to treatment
Time frame: Day 0
Change in CD4+ T cells during treatment
Time frame: Day 0
Viremia at inclusion into the study
Time frame: Day 0
Viremia during the 2 previous years
Time frame: Day 0
Residual immune activation at inclusion into the study
Time frame: Day 0
Residual immune activation during the previous 2 years
Time frame: Day 0
Nature of current treatment
Time frame: Day 0
Co-infection with hepatitis C virus
Time frame: Day 0
Co-infection with hepatitis B virus
Time frame: Day 0
Co-infection with Cytomegalovirus
Time frame: Day 0
Co-infection with Epstein-Barr virus
Time frame: Day 0
Testing for intact proviral DNA
Time frame: Day 0
Circulating viral RNA sequence
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Pierre Corbeau, MD principal investigator
CHU Nimes
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 Centre Hospitalier Universitaire de Nīmes 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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of CD4+ T cells expressing CD32 alone (time frame: Day 0). The study lists 4 primary outcomes in all. 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 17 Nov 2025.