HIVDOLUTECAPSNCT02878642
Adherence to Dolutegravir and Outcome
An observational study of HIV, run by University Hospital, Caen at 1 site in France.
Trial summary
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Dec 2017
- 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: Patients infected with HIV-1 treated with dolutegravir at week 16 and week 24
Who may be able to join
- HIV-1
- Age over 18 years
- Information letter signed
- ART (antiretroviral therapy) with at least 3 active molecules
- Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)
Who cannot join
- pregnant woman
- HIV-2
- Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization)
- Patient receiving aid incompatible with compliance with the use of electronic pillbox
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Jean Jacques PARIENTI, MD, PhD, parienti-jj@chu-caen.fr
About this study
Official title: Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).
While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to dolutegravir measured by the electronic pill boxes
Calculating the total compliance
Measured: From baseline up to week 24
Virologic Efficacy
Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.
Measured: week 24
Secondary outcomes (1)
Patient Genotype resistance if failure
Measured: Week 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878642
- Sponsor's protocol ID
- 13-184
- Acronym
- DOLUTECAPS
- Status last verified
- Jan 2017
- First submitted
- 27 May 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)
- ClinicalTrials.gov ID
- NCT02878642
- Acronym / sponsor ID
- DOLUTECAPS / 13-184
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017
- First posted
- 25 Aug 2016 (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.
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).
While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients infected with HIV-1 treated with dolutegravir at week 16 and week 24
Key inclusion criteria (5 listed)
- HIV-1
- Age over 18 years
- Information letter signed
- ART (antiretroviral therapy) with at least 3 active molecules
- Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)
Key exclusion criteria (4 listed)
- pregnant woman
- HIV-2
- Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization)
- Patient receiving aid incompatible with compliance with the use of electronic pillbox
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to dolutegravir measured by the electronic pill boxes
Time frame: From baseline up to week 24
Calculating the total compliance
Virologic Efficacy
Time frame: week 24
Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.
1 secondary outcome
Patient Genotype resistance if failure
Time frame: Week 16 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
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, run by University Hospital, Caen 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 4 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 1 Feb 2017. 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 Jean Jacques PARIENTI, MD,PhD (02 31 06 43 20 ext. +33, parienti-jj@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to dolutegravir measured by the electronic pill boxes (time frame: From baseline up to week 24). The study lists 2 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 1 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.