Infection, Human Immunodeficiency Virus INCT03327740
PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)
An observational study of Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare.
Trial summary
Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I
- What is being tested?
- DTG based ARV regimen with ABC, DTG based ARV regimen without ABC and RAL or EGV based ARV regimens with ABC
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2014to 31 Dec 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or users of other integrase inhibitor regimens (RAL and EGV).
Who may be able to join
- New users of DTG or users of other integrase inhibitor regimens (RAL and EGV)
Who cannot join
- None
About this study
Official title: A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (With and Without Abacavir) or Other Integrase Inhibitors (With or Without Abacavir)
Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV). Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC. This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study. The study population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens for any reason.
- Being tested
- DTG based ARV regimen with ABC, DTG based ARV regimen without ABC, RAL or EGV based ARV regimens with ABC, RAL or EGV based regimens without ABC, Any other DTG based ARV regimen as monotherapy
- Keywords
- Hypersensitivity reactions (HSR), HIV, Dolutegravir
- Medical subject headings
- Infections, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTG based ARV regimen with ABCDrug
ARV regimens containing DTG and ABC
DTG based ARV regimen without ABCDrug
DTG based ARV regimens that do not contain ABC
RAL or EGV based ARV regimens with ABCDrug
RAL or EGV based regimens containing ABC
RAL or EGV based regimens without ABCDrug
RAL or EGV based ARV regimens that do not contain ABC
Any other DTG based ARV regimen as monotherapyDrug
Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.
| Study group | Role | What they receive |
|---|---|---|
| Subjects on DTG based ARV with ABC | These are subjects who begin a DTG based ARV regimen that includes ABC Receives: Drug: DTG based ARV regimen with ABC | |
| Subjects that start DTG based ARV regimen but without ABC | These are subjects who begin a DTG-based ARV regimen that does not contain ABC Receives: Drug: DTG based ARV regimen without ABC | |
| Subjects on other integrase inhibitor based regimen with ABC | These are subjects who begin other integrase inhibitor based regimens (RAL and EGV) that contains ABC Receives: Drug: RAL or EGV based ARV regimens with ABC | |
| Subjects on other integrase inhibitor based regimen but no ABC | These are subjects that start non-ABC containing RAL or EGV based regimens Receives: Drug: RAL or EGV based regimens without ABC | |
| Subjects that start any other DTG based ARV regimen | These are subjects who begin any other DTG based ARV regimen that will include DTG as monotherapy or two-drug regimens Receives: Drug: Any other DTG based ARV regimen as monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with occurrence of hypersensitivity reactions (HSR), of any grade
Hypersensitivity reactions including fever, rash, gastrointestinal symptoms, constitutional symptoms, respiratory symptoms and eosinophilia will be summarized.
Measured: Up to 5 years
Number of subjects with hepatic dysfunction
Hepatic dysfunction will be indicated by liver chemistry tests
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start30 Sep 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327740
- Sponsor's protocol ID
- 201177
- Other IDs
- PRJ2203
- Status last verified
- Feb 2020
- First submitted
- 27 Oct 2017
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (With and Without Abacavir) or Other Integrase Inhibitors (With or Without Abacavir)
- ClinicalTrials.gov ID
- NCT03327740
- Acronym / sponsor ID
- 201177
- Keywords
- Hypersensitivity reactions (HSR), HIV, Dolutegravir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Oct 2017 (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.
Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV). Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC. This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study. The study population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens for any reason.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjects on DTG based ARV with ABC | – | Drug: DTG based ARV regimen with ABCThese are subjects who begin a DTG based ARV regimen that includes ABC |
| Subjects that start DTG based ARV regimen but without ABC | – | Drug: DTG based ARV regimen without ABCThese are subjects who begin a DTG-based ARV regimen that does not contain ABC |
| Subjects on other integrase inhibitor based regimen with ABC | – | Drug: RAL or EGV based ARV regimens with ABCThese are subjects who begin other integrase inhibitor based regimens (RAL and EGV) that contains ABC |
| Subjects on other integrase inhibitor based regimen but no ABC | – | Drug: RAL or EGV based regimens without ABCThese are subjects that start non-ABC containing RAL or EGV based regimens |
| Subjects that start any other DTG based ARV regimen | – | Drug: Any other DTG based ARV regimen as monotherapyThese are subjects who begin any other DTG based ARV regimen that will include DTG as monotherapy or two-drug regimens |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or users of other integrase inhibitor regimens (RAL and EGV).
Key inclusion criteria (1 listed)
- New users of DTG or users of other integrase inhibitor regimens (RAL and EGV)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DTG based ARV regimen with ABCARV regimens containing DTG and ABC | Drug | Subjects on DTG based ARV with ABC |
| DTG based ARV regimen without ABCDTG based ARV regimens that do not contain ABC | Drug | Subjects that start DTG based ARV regimen but without ABC |
| RAL or EGV based ARV regimens with ABCRAL or EGV based regimens containing ABC | Drug | Subjects on other integrase inhibitor based regimen with ABC |
| RAL or EGV based regimens without ABCRAL or EGV based ARV regimens that do not contain ABC | Drug | Subjects on other integrase inhibitor based regimen but no ABC |
| Any other DTG based ARV regimen as monotherapyAny other DTG based ARV regimens including DTG as monotherapy or two-drug regimens. | Drug | Subjects that start any other DTG based ARV regimen |
Primary outcome
Number of subjects with occurrence of hypersensitivity reactions (HSR), of any grade
Time frame: Up to 5 years
Hypersensitivity reactions including fever, rash, gastrointestinal symptoms, constitutional symptoms, respiratory symptoms and eosinophilia will be summarized.
Number of subjects with hepatic dysfunction
Time frame: Up to 5 years
Hepatic dysfunction will be indicated by liver chemistry tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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.
GSK Clinical Trials study director
ViiV Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with occurrence of hypersensitivity reactions (HSR), of any grade (time frame: Up to 5 years). 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 6 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.