HIV InfectionsINKASENCT05243381
Inflammation, NK Cells, Antisense Protein and Exosomes, and Correlation With Immune Response During HIV Infection
A study testing 20 ml blood test in people with HIV Infections, run by University Hospital, Montpellier at 1 site in France.
Trial summary
More than 90% of HIV-infected patients on antiretroviral therapy have an undetectable viral load. However, approximately 15% of these individuals do not sufficiently restore their TCD4 lymphocytes and have an unfavorable CD4/CD8 ratio despite good adherence and an undetectable viral load. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- 20 ml blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2022to Apr 2024
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patiens living with HIV over 45 years old
- At least 2 measurements of CD4+ T-cell and HIV viral load in the last 2 years
- HIV viral load < 50 copies/ml in the past 2 years
- For the immune non-responder patients : CD4+ T-cell count < 350 cells/mm3 on the last two tests
- For the immune responder patients: CD4+ T-cell count > 500 cells/mm3 on the last two tests
Who cannot join
- No antiretroviral treatment
- Immunosuppressive treatment
- History of cancer less than 5 years
- Pregnancy
- Breastfeeding mother
- Adult protected by law or patient under guardianship or curatorship
- Failure to obtain written informed consent after a reflection period
- Not be affiliated to a French social security system or a beneficiary of such a system
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
La Colombiere Hospital
Montpellier, Herault, 34295
Charlotte SILVESTRE, PharmD, +33434359441, charlotte.silvestre@irim.cnrs.fr
About this study
More than 90% of HIV-infected patients on antiretroviral therapy have an undetectable viral load. However, approximately 15% of these individuals do not sufficiently restore their TCD4 lymphocytes and have an unfavorable CD4/CD8 ratio despite good adherence and an undetectable viral load. Factors associated with immunovirological discordance include low CD4 cell counts prior to antiretroviral therapy, low CD4/CD8 ratios and positive cytomegalovirus (CMV) serology. These patients are at risk of significant non-AIDS events and mortality.
The anti-sense protein (ASP) is synthesized from the anti-sense strand of HIV-1. A cytotoxic anti-ASP response of CD8 T lymphocytes and anti-ASP antibodies have been demonstrated in infected patients. The conservation of the ASP gene in HIV-1, the virus responsible for the pandemic, suggests that its maintenance confers an advantage to the virus. ASP induces an inflammatory phenotype in surrounding cells. ASP can be externalized by the cell through its interaction with its cellular partner Bat-3. Once externalized in soluble or exosomal form, Bat-3 has the ability to regulate NK cell activity. During HIV infection, NK functions are disrupted, including those related to the expression of the Bat-3 receptor, NKp30.
Read more
In patients, the inflammatory phenomenon is strongly associated with chronic HIV-1 infection. The efficacy of antiviral treatments does not allow a complete normalization of either the immune system function or the inflammatory status of the patient. The observed effect of ASP on inflammation raises the question of the involvement of ASP in the maintenance of a chronic inflammatory state in patients under treatment. Increased inflammation has also been associated in HIV-infected patients with elevated plasma exosome levels. In patients undergoing treatment, chronic inflammation remains a major problem and an important source of comorbidities (cardiovascular in particular) and probably contributes to the immunovirological non-response in immunodiscordant HIV-infected patients.
It is hypothesized that ASP bound to its cellular partner Bat-3 in exosomes would disrupt the cytotoxic activity of NK cells, sustain inflammation and have a deleterious effect on immune reconstitution.
Read the detailed description
The main objective of the project is to characterize the presence of ex vivo NK cell perturbations in patients living with HIV (PLHIV) with immunovirological discordance, in relation to ASP expression and plasmatic exosomes. The secondary objectives will be to identify new biological parameters to study and to establish mechanistic hypothesis explaining the results obtained during the study.
The study has a pathophysiological aim and is approved by the committee for the protection of individuals. Two groups of patients will be constituted: one group of PLWHIV with immunovirological discordance (20 patients) and the other group of PLWHIV with a good immune reconstitution (40 patients).
- Conditions
- HIV Infections
- Being tested
- 20 ml blood test
- Keywords
- Immune non-responder HIV-patients, Immune responder HIV-patients, HIV-1 antisense protein, Exosomes, NK cells
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 ml blood testBiological
20 ml blood test
| Study group | Role | What they receive |
|---|---|---|
| Immune non-responder patients | Other | * HIV viral load < 50 copies/ml in the past 2 years
* CD4+ T-cell count < 350 cells/mm3 on the last two tests Receives: Biological: 20 ml blood test |
| Immune responder patients | Other | * HIV viral load < 50 copies/ml in the past 2 years
* CD4+ T-cell count > 500 cells/mm3 on the last two tests Receives: Biological: 20 ml blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune status of HIV-infected patients
CD4+ T-cell count
Measured: The day of inclusion
Secondary outcomes (4)
HIV-1 Antisense protein
HIV-1 antisense protein expression level
Measured: The day of inclusion
Impacts of exosomes on NK cell activity
Cytotoxicity activity and cytokines production (intracellular staining and qRT-PCR) during cytotoxicity assay
Measured: The day of inclusion
NK cells phenotyping
Flow cytometry phenotyping: subpopulation, activation and exhaustion markers
Measured: The day of inclusion
NK cells functionality
Natural and antibody-dependent cytotoxicity assays
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start22 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain MAKINSON, MH PD, Principal investigator, UH MONTPELLIERAntoine GROSS, PHD, Study director, Centre National de la Recherche Scientifique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243381
- Sponsor's protocol ID
- RECHMPL21_0518
- Acronym
- INKASE
- Status last verified
- Sep 2022
- First submitted
- 24 Jan 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landry S, Halin M, Lefort S, Audet B, Vaquero C, Mesnard JM, Barbeau B. Detection, characterization and regulation of antisense transcripts in HIV-1. Retrovirology. 2007 Oct 2;4:71. doi: 10.1186/1742-4690-4-71.
PubMed 17910760Laverdure S, Gross A, Arpin-Andre C, Clerc I, Beaumelle B, Barbeau B, Mesnard JM. HIV-1 antisense transcription is preferentially activated in primary monocyte-derived cells. J Virol. 2012 Dec;86(24):13785-9. doi: 10.1128/JVI.01723-12. Epub 2012 Oct 3.
PubMed 23035216Bet A, Maze EA, Bansal A, Sterrett S, Gross A, Graff-Dubois S, Samri A, Guihot A, Katlama C, Theodorou I, Mesnard JM, Moris A, Goepfert PA, Cardinaud S. The HIV-1 antisense protein (ASP) induces CD8 T cell responses during chronic infection. Retrovirology. 2015 Feb 10;12:15. doi: 10.1186/s12977-015-0135-y.
PubMed 25809376Savoret J, Chazal N, Moles JP, Tuaillon E, Boufassa F, Meyer L, Lecuroux C, Lambotte O, Van De Perre P, Mesnard JM, Gross A. A Pilot Study of the Humoral Response Against the AntiSense Protein (ASP) in HIV-1-Infected Patients. Front Microbiol. 2020 Jan 24;11:20. doi: 10.3389/fmicb.2020.00020. eCollection 2020.
PubMed 32117090Cassan E, Arigon-Chifolleau AM, Mesnard JM, Gross A, Gascuel O. Concomitant emergence of the antisense protein gene of HIV-1 and of the pandemic. Proc Natl Acad Sci U S A. 2016 Oct 11;113(41):11537-11542. doi: 10.1073/pnas.1605739113. Epub 2016 Sep 28.
PubMed 27681623Wang Y, Lifshitz L, Gellatly K, Vinton CL, Busman-Sahay K, McCauley S, Vangala P, Kim K, Derr A, Jaiswal S, Kucukural A, McDonel P, Hunt PW, Greenough T, Houghton J, Somsouk M, Estes JD, Brenchley JM, Garber M, Deeks SG, Luban J. HIV-1-induced cytokines deplete homeostatic innate lymphoid cells and expand TCF7-dependent memory NK cells. Nat Immunol. 2020 Mar;21(3):274-286. doi: 10.1038/s41590-020-0593-9. Epub 2020 Feb 17.
PubMed 32066947Giuliani E, Vassena L, Di Cesare S, Malagnino V, Desimio MG, Andreoni M, Barnaba V, Doria M. NK cells of HIV-1-infected patients with poor CD4+ T-cell reconstitution despite suppressive HAART show reduced IFN-gamma production and high frequency of autoreactive CD56bright cells. Immunol Lett. 2017 Oct;190:185-193. doi: 10.1016/j.imlet.2017.08.014. Epub 2017 Aug 19.
PubMed 28826739Florez-Alvarez L, Hernandez JC, Zapata W. NK Cells in HIV-1 Infection: From Basic Science to Vaccine Strategies. Front Immunol. 2018 Oct 17;9:2290. doi: 10.3389/fimmu.2018.02290. eCollection 2018.
PubMed 30386329Lucar O, Reeves RK, Jost S. A Natural Impact: NK Cells at the Intersection of Cancer and HIV Disease. Front Immunol. 2019 Aug 14;10:1850. doi: 10.3389/fimmu.2019.01850. eCollection 2019.
PubMed 31474977Perez PS, Romaniuk MA, Duette GA, Zhao Z, Huang Y, Martin-Jaular L, Witwer KW, Thery C, Ostrowski M. Extracellular vesicles and chronic inflammation during HIV infection. J Extracell Vesicles. 2019 Nov 6;8(1):1687275. doi: 10.1080/20013078.2019.1687275. eCollection 2019.
PubMed 31998449Pantazis N, Papastamopoulos V, Paparizos V, Metallidis S, Adamis G, Antoniadou A, Psichogiou M, Chini M, Sambatakou H, Sipsas NV, Gogos C, Chrysos G, Panagopoulos P, Katsarou O, Gikas A, Touloumi G; AMACS. Long-term evolution of CD4+ cell count in patients under combined antiretroviral therapy. AIDS. 2019 Aug 1;33(10):1645-1655. doi: 10.1097/QAD.0000000000002248.
PubMed 31305332Gras L, May M, Ryder LP, Trickey A, Helleberg M, Obel N, Thiebaut R, Guest J, Gill J, Crane H, Dias Lima V, d'Arminio Monforte A, Sterling TR, Miro J, Moreno S, Stephan C, Smith C, Tate J, Shepherd L, Saag M, Rieger A, Gillor D, Cavassini M, Montero M, Ingle SM, Reiss P, Costagliola D, Wit FWNM, Sterne J, de Wolf F, Geskus R; Antiretroviral Therapy Cohort Collaboration (ART-CC). Determinants of Restoration of CD4 and CD8 Cell Counts and Their Ratio in HIV-1-Positive Individuals With Sustained Virological Suppression on Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2019 Mar 1;80(3):292-300. doi: 10.1097/QAI.0000000000001913.
PubMed 30531492Roul H, Mary-Krause M, Ghosn J, Delaugerre C, Pialoux G, Cuzin L, Launay O, Lacombe JM, Menard A, De Truchis P, Delfraissy JF, Weiss L, Costagliola D; FHDH-ANRS CO4. CD4+ cell count recovery after combined antiretroviral therapy in the modern combined antiretroviral therapy era. AIDS. 2018 Nov 13;32(17):2605-2614. doi: 10.1097/QAD.0000000000002010.
PubMed 30289817Mussini C, Lorenzini P, Cozzi-Lepri A, Lapadula G, Marchetti G, Nicastri E, Cingolani A, Lichtner M, Antinori A, Gori A, d'Arminio Monforte A; Icona Foundation Study Group. CD4/CD8 ratio normalisation and non-AIDS-related events in individuals with HIV who achieve viral load suppression with antiretroviral therapy: an observational cohort study. Lancet HIV. 2015 Mar;2(3):e98-106. doi: 10.1016/S2352-3018(15)00006-5. Epub 2015 Feb 6.
PubMed 26424550Silvestre C, Tuaillon E, Duroyon MM, Abrantes M, Thibout JC, Villalba M, Picot MC, Gross A, Makinson A. NK Count and Natural Cytotoxicity in Immune Nonresponders Versus Responders Living With HIV. J Med Virol. 2025 Feb;97(2):e70170. doi: 10.1002/jmv.70170.
PubMed 39868926
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, NK Cells, Antisense Protein and Exosomes, and Correlation With Immune Response During HIV Infection
- ClinicalTrials.gov ID
- NCT05243381
- Acronym / sponsor ID
- INKASE / RECHMPL21_0518
- Conditions
- HIV Infections
- Keywords
- Immune non-responder HIV-patients, Immune responder HIV-patients, HIV-1 antisense protein, Exosomes, NK cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 17 Feb 2022 (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.
More than 90% of HIV-infected patients on antiretroviral therapy have an undetectable viral load. However, approximately 15% of these individuals do not sufficiently restore their TCD4 lymphocytes and have an unfavorable CD4/CD8 ratio despite good adherence and an undetectable viral load. Factors associated with immunovirological discordance include low CD4 cell counts prior to antiretroviral therapy, low CD4/CD8 ratios and positive cytomegalovirus (CMV) serology. These patients are at risk of significant non-AIDS events and mortality.
The anti-sense protein (ASP) is synthesized from the anti-sense strand of HIV-1. A cytotoxic anti-ASP response of CD8 T lymphocytes and anti-ASP antibodies have been demonstrated in infected patients. The conservation of the ASP gene in HIV-1, the virus responsible for the pandemic, suggests that its maintenance confers an advantage to the virus. ASP induces an inflammatory phenotype in surrounding cells. ASP can be externalized by the cell through its interaction with its cellular partner Bat-3. Once externalized in soluble or exosomal form, Bat-3 has the ability to regulate NK cell activity. During HIV infection, NK functions are disrupted, including those related to the expression of the Bat-3 receptor, NKp30.
In patients, the inflammatory phenomenon is strongly associated with chronic HIV-1 infection. The efficacy of antiviral treatments does not allow a complete normalization of either the immune system function or the inflammatory status of the patient. The observed effect of ASP on inflammation raises the question of the involvement of ASP in the maintenance of a chronic inflammatory state in patients under treatment. Increased inflammation has also been associated in HIV-infected patients with elevated plasma exosome levels. In patients undergoing treatment, chronic inflammation remains a major problem and an important source of comorbidities (cardiovascular in particular) and probably contributes to the immunovirological non-response in immunodiscordant HIV-infected patients.
It is hypothesized that ASP bound to its cellular partner Bat-3 in exosomes would disrupt the cytotoxic activity of NK cells, sustain inflammation and have a deleterious effect on immune reconstitution.
Detailed description
The main objective of the project is to characterize the presence of ex vivo NK cell perturbations in patients living with HIV (PLHIV) with immunovirological discordance, in relation to ASP expression and plasmatic exosomes. The secondary objectives will be to identify new biological parameters to study and to establish mechanistic hypothesis explaining the results obtained during the study.
The study has a pathophysiological aim and is approved by the committee for the protection of individuals. Two groups of patients will be constituted: one group of PLWHIV with immunovirological discordance (20 patients) and the other group of PLWHIV with a good immune reconstitution (40 patients).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune non-responder patients | Other | Biological: 20 ml blood test* HIV viral load < 50 copies/ml in the past 2 years * CD4+ T-cell count < 350 cells/mm3 on the last two tests |
| Immune responder patients | Other | Biological: 20 ml blood test* HIV viral load < 50 copies/ml in the past 2 years * CD4+ T-cell count > 500 cells/mm3 on the last two tests |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patiens living with HIV over 45 years old
- At least 2 measurements of CD4+ T-cell and HIV viral load in the last 2 years
- HIV viral load < 50 copies/ml in the past 2 years
- For the immune non-responder patients : CD4+ T-cell count < 350 cells/mm3 on the last two tests
- For the immune responder patients: CD4+ T-cell count > 500 cells/mm3 on the last two tests
Key exclusion criteria (8 listed)
- No antiretroviral treatment
- Immunosuppressive treatment
- History of cancer less than 5 years
- Pregnancy
- Breastfeeding mother
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 |
|---|---|---|
| 20 ml blood test20 ml blood test | Biological | Immune non-responder patients, Immune responder patients |
Primary outcome
Immune status of HIV-infected patients
Time frame: The day of inclusion
CD4+ T-cell count
4 secondary outcomes
HIV-1 Antisense protein
Time frame: The day of inclusion
Impacts of exosomes on NK cell activity
Time frame: The day of inclusion
NK cells phenotyping
Time frame: The day of inclusion
NK cells functionality
Time frame: The day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 17910760Landry S, Halin M, Lefort S, Audet B, Vaquero C, Mesnard JM, Barbeau B. Detection, characterization and regulation of antisense transcripts in HIV-1. Retrovirology. 2007 Oct 2;4:71. doi: 10.1186/1742-4690-4-71.
- Background: PubMed 23035216Laverdure S, Gross A, Arpin-Andre C, Clerc I, Beaumelle B, Barbeau B, Mesnard JM. HIV-1 antisense transcription is preferentially activated in primary monocyte-derived cells. J Virol. 2012 Dec;86(24):13785-9. doi: 10.1128/JVI.01723-12. Epub 2012 Oct 3.
- Background: PubMed 25809376Bet A, Maze EA, Bansal A, Sterrett S, Gross A, Graff-Dubois S, Samri A, Guihot A, Katlama C, Theodorou I, Mesnard JM, Moris A, Goepfert PA, Cardinaud S. The HIV-1 antisense protein (ASP) induces CD8 T cell responses during chronic infection. Retrovirology. 2015 Feb 10;12:15. doi: 10.1186/s12977-015-0135-y.
- Background: PubMed 32117090Savoret J, Chazal N, Moles JP, Tuaillon E, Boufassa F, Meyer L, Lecuroux C, Lambotte O, Van De Perre P, Mesnard JM, Gross A. A Pilot Study of the Humoral Response Against the AntiSense Protein (ASP) in HIV-1-Infected Patients. Front Microbiol. 2020 Jan 24;11:20. doi: 10.3389/fmicb.2020.00020. eCollection 2020.
- Background: PubMed 27681623Cassan E, Arigon-Chifolleau AM, Mesnard JM, Gross A, Gascuel O. Concomitant emergence of the antisense protein gene of HIV-1 and of the pandemic. Proc Natl Acad Sci U S A. 2016 Oct 11;113(41):11537-11542. doi: 10.1073/pnas.1605739113. Epub 2016 Sep 28.
- Background: PubMed 32066947Wang Y, Lifshitz L, Gellatly K, Vinton CL, Busman-Sahay K, McCauley S, Vangala P, Kim K, Derr A, Jaiswal S, Kucukural A, McDonel P, Hunt PW, Greenough T, Houghton J, Somsouk M, Estes JD, Brenchley JM, Garber M, Deeks SG, Luban J. HIV-1-induced cytokines deplete homeostatic innate lymphoid cells and expand TCF7-dependent memory NK cells. Nat Immunol. 2020 Mar;21(3):274-286. doi: 10.1038/s41590-020-0593-9. Epub 2020 Feb 17.
- Background: PubMed 28826739Giuliani E, Vassena L, Di Cesare S, Malagnino V, Desimio MG, Andreoni M, Barnaba V, Doria M. NK cells of HIV-1-infected patients with poor CD4+ T-cell reconstitution despite suppressive HAART show reduced IFN-gamma production and high frequency of autoreactive CD56bright cells. Immunol Lett. 2017 Oct;190:185-193. doi: 10.1016/j.imlet.2017.08.014. Epub 2017 Aug 19.
- Background: PubMed 30386329Florez-Alvarez L, Hernandez JC, Zapata W. NK Cells in HIV-1 Infection: From Basic Science to Vaccine Strategies. Front Immunol. 2018 Oct 17;9:2290. doi: 10.3389/fimmu.2018.02290. eCollection 2018.
- Background: PubMed 31474977Lucar O, Reeves RK, Jost S. A Natural Impact: NK Cells at the Intersection of Cancer and HIV Disease. Front Immunol. 2019 Aug 14;10:1850. doi: 10.3389/fimmu.2019.01850. eCollection 2019.
- Background: PubMed 31998449Perez PS, Romaniuk MA, Duette GA, Zhao Z, Huang Y, Martin-Jaular L, Witwer KW, Thery C, Ostrowski M. Extracellular vesicles and chronic inflammation during HIV infection. J Extracell Vesicles. 2019 Nov 6;8(1):1687275. doi: 10.1080/20013078.2019.1687275. eCollection 2019.
- Background: PubMed 31305332Pantazis N, Papastamopoulos V, Paparizos V, Metallidis S, Adamis G, Antoniadou A, Psichogiou M, Chini M, Sambatakou H, Sipsas NV, Gogos C, Chrysos G, Panagopoulos P, Katsarou O, Gikas A, Touloumi G; AMACS. Long-term evolution of CD4+ cell count in patients under combined antiretroviral therapy. AIDS. 2019 Aug 1;33(10):1645-1655. doi: 10.1097/QAD.0000000000002248.
- Background: PubMed 30531492Gras L, May M, Ryder LP, Trickey A, Helleberg M, Obel N, Thiebaut R, Guest J, Gill J, Crane H, Dias Lima V, d'Arminio Monforte A, Sterling TR, Miro J, Moreno S, Stephan C, Smith C, Tate J, Shepherd L, Saag M, Rieger A, Gillor D, Cavassini M, Montero M, Ingle SM, Reiss P, Costagliola D, Wit FWNM, Sterne J, de Wolf F, Geskus R; Antiretroviral Therapy Cohort Collaboration (ART-CC). Determinants of Restoration of CD4 and CD8 Cell Counts and Their Ratio in HIV-1-Positive Individuals With Sustained Virological Suppression on Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2019 Mar 1;80(3):292-300. doi: 10.1097/QAI.0000000000001913.
- 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.
Alain MAKINSON, MH PD principal investigator
UH MONTPELLIER
Antoine GROSS, PHD study director
Centre National de la Recherche Scientifique, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 ml blood test in people with HIV Infections, run by University Hospital, Montpellier 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 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain MAKINSON, MH PD (+33467339510, a-makinson@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune status of HIV-infected patients (time frame: The day of inclusion). 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 NCT05243381, which also lists 15 linked publications.
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 7 Sep 2022.