HIV-1 InfectionPhase 4DRONENCT02370979
Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
A Phase 4 study testing Blood samples in people with HIV-1 Infection, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by 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 samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2015to Jul 2017
- Phase
- Phase 4
- 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
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
- An active AIDS-defining condition at Screening
- 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
4 sites in 1 country.
France4 sites, 3 recruiting
- Active, not recruiting
Centre hospitalier de Belfort-Montbéliard
Belfort, 90000
- Recruiting
Centre hospitalier de Colmar
Colmar, 68024
Martin MARTINOT, MD, martin.martinot@ch-colmar.fr
- Recruiting
Centre hospitalier de Mulhouse
Mulhouse, 68070
Geneviève BECK WIRTH, MD, beck-wirthg@ch-mulhouse.fr
- Recruiting
Hôpitaux Universitaire de Strasbourg
Strasbourg, 67091
David REY, PhD, david.rey@chru-strasbourg.fr
About this study
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.
- Conditions
- HIV-1 Infection
- Being tested
- Blood samples
- Keywords
- Dolutegravir, Proviral HIV-1 DNA, Reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir | Experimental | Not described Receives: Biological: Blood samples |
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 (Day 0) and Week 48
Secondary outcomes (2)
Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)
Measured: Week 4, Week 24 and Week 48
Quantification of biomarkers of immune activation
CRPus, IL-6, neopterin, D-dimer, CD14s
Measured: baseline (Day 0), Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David REY, PhD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370979
- Sponsor's protocol ID
- 5973
- Acronym
- DRONE
- Status last verified
- Aug 2015
- First submitted
- 26 Jan 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
- ClinicalTrials.gov ID
- NCT02370979
- Acronym / sponsor ID
- DRONE / 5973
- Conditions
- HIV-1 Infection
- Keywords
- Dolutegravir, Proviral HIV-1 DNA, Reservoir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Feb 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.
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir | Experimental | Biological: Blood samples |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (8 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
- An active AIDS-defining condition at Screening
- Documented resistance to DTG
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 samples | Biological | Dolutegravir |
Primary outcome
Change from baseline in Proviral HIV-1 DNA at Week 48
Time frame: baseline (Day 0) and Week 48
2 secondary outcomes
Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)
Time frame: Week 4, Week 24 and Week 48
Quantification of biomarkers of immune activation
Time frame: baseline (Day 0), Week 24 and Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
David REY, PhD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood samples in people with HIV-1 Infection, run by University Hospital, Strasbourg, France at 4 sites 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 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+33369551438, 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 (Day 0) and Week 48). 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 7 Aug 2015.