HIV-1 InfectionNCT02557997
Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
An observational study of HIV-1 Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Blood tube bottom analyses
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting an HIV Infection care center at a university hospital will be selected
Who may be able to join
- Male or female aged from de 18 to 80 years
- Patient starting a DTG-regimen
- Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
- Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
Who cannot join
- Women who are pregnant or breastfeeding
- HBV or HCV coinfection
- Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
- Documented resistance to DTG
- Allergy or intolerance to the study drugs or their components or drugs of their class
- Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
- Coadministration with Dofelitide
Trial locations and contacts
1 site in 1 country.
Samira FAFI-KREMER, PhD contact
Pierre GANTNER, PhD contact
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg - Trait d'Union
Strasbourg, 67091
David REY, MD, david.rey@chru-strasbourg.fr
About this study
We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.
- Conditions
- HIV-1 Infection
- Being tested
- Blood tube bottom analyses
- Keywords
- HIV reservoir, HIV-1 DNA, Immune activation, Monocyte function, Activation biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood tube bottom analysesOther
| Study group | Role | What they receive |
|---|---|---|
| ART-naive (primary infection) | ART-naive (primary infection) HIV infected adults Receives: Other: Blood tube bottom analyses | |
| ART-naïve (chronic infection) | ART-naïve (chronic infection) HIV infected adults Receives: Other: Blood tube bottom analyses | |
| ART-controlled | ART-controlled HIV infected adults Receives: Other: Blood tube bottom analyses | |
| ART-failing | ART-failing HIV infected adults Receives: Other: Blood tube bottom analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Proviral HIV-1 DNA at Week 48
Measured: Baseline and 48 weeks post DTG-based regimen initiation
Secondary outcomes (1)
Quantification of biomarkers of immune activation
Soluble CD14 (sCD14), soluble CD163 (sCD163), neopterine, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP)
Measured: Baseline, 24 and 48 weeks post DTG-based regimen initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557997
- Sponsor's protocol ID
- 6074
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gantner P, Barnig C, Partisani M, Lee GQ, Beck-Wirth G, Faller JP, Martinot M, Mosheni-Zadeh M, Cheneau C, Batard ML, Fischer P, Fuchs A, Uring-Lambert B, Bahram S, Rey D, Fafi-Kremer S. Distribution and reduction magnitude of HIV-DNA burden in CD4+ T cell subsets depend on art initiation timing. AIDS. 2018 Apr 24;32(7):921-926. doi: 10.1097/QAD.0000000000001770.
PubMed 29424775Gantner P, Lee GQ, Rey D, Mesplede T, Partisani M, Cheneau C, Beck-Wirth G, Faller JP, Mohseni-Zadeh M, Martinot M, Wainberg MA, Fafi-Kremer S. Dolutegravir reshapes the genetic diversity of HIV-1 reservoirs. J Antimicrob Chemother. 2018 Apr 1;73(4):1045-1053. doi: 10.1093/jac/dkx475.
PubMed 29244129
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
- ClinicalTrials.gov ID
- NCT02557997
- Acronym / sponsor ID
- 6074
- Conditions
- HIV-1 Infection
- Keywords
- HIV reservoir, HIV-1 DNA, Immune activation, Monocyte function, Activation biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 23 Sep 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.
We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART-naive (primary infection) | – | Other: Blood tube bottom analysesART-naive (primary infection) HIV infected adults |
| ART-naïve (chronic infection) | – | Other: Blood tube bottom analysesART-naïve (chronic infection) HIV infected adults |
| ART-controlled | – | Other: Blood tube bottom analysesART-controlled HIV infected adults |
| ART-failing | – | Other: Blood tube bottom analysesART-failing HIV infected adults |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting an HIV Infection care center at a university hospital will be selected
Key inclusion criteria (4 listed)
- Male or female aged from de 18 to 80 years
- Patient starting a DTG-regimen
- Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
- Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
Key exclusion criteria (7 listed)
- Women who are pregnant or breastfeeding
- HBV or HCV coinfection
- Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
- Documented resistance to DTG
- Allergy or intolerance to the study drugs or their components or drugs of their class
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 |
|---|---|---|
| Blood tube bottom analyses | Other | ART-controlled, ART-failing, ART-naive (primary infection), ART-naïve (chronic infection) |
Primary outcome
Change from baseline in Proviral HIV-1 DNA at Week 48
Time frame: Baseline and 48 weeks post DTG-based regimen initiation
1 secondary outcome
Quantification of biomarkers of immune activation
Time frame: Baseline, 24 and 48 weeks post DTG-based regimen initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 29424775Gantner P, Barnig C, Partisani M, Lee GQ, Beck-Wirth G, Faller JP, Martinot M, Mosheni-Zadeh M, Cheneau C, Batard ML, Fischer P, Fuchs A, Uring-Lambert B, Bahram S, Rey D, Fafi-Kremer S. Distribution and reduction magnitude of HIV-DNA burden in CD4+ T cell subsets depend on art initiation timing. AIDS. 2018 Apr 24;32(7):921-926. doi: 10.1097/QAD.0000000000001770.
- Derived from this study: PubMed 29244129Gantner P, Lee GQ, Rey D, Mesplede T, Partisani M, Cheneau C, Beck-Wirth G, Faller JP, Mohseni-Zadeh M, Martinot M, Wainberg MA, Fafi-Kremer S. Dolutegravir reshapes the genetic diversity of HIV-1 reservoirs. J Antimicrob Chemother. 2018 Apr 1;73(4):1045-1053. doi: 10.1093/jac/dkx475.
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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.
Samira FAFI-KREMER, PhD contact
Pierre GANTNER, PhD contact
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 University Hospital, Strasbourg, France 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 7 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 23 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira FAFI-KREMER, PhD (samira.fafi-kremer@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Proviral HIV-1 DNA at Week 48 (time frame: Baseline and 48 weeks post DTG-based regimen initiation). 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 NCT02557997, which also lists 2 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 23 Sep 2015.