An observational study in Infection, Human Immunodeficiency Virus I, sponsored by ViiV Healthcare. Completed. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Observational
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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.
2,094 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 1 is below the median of 300 across 686 observational studies indexed under Infections.
Browse Infections studies →ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
These are subjects who begin a DTG based ARV regimen that includes ABC
Drug: DTG based ARV regimen with ABC
These are subjects who begin a DTG-based ARV regimen that does not contain ABC
Drug: DTG based ARV regimen without ABC
These are subjects who begin other integrase inhibitor based regimens (RAL and EGV) that contains ABC
Drug: RAL or EGV based ARV regimens with ABC
These are subjects that start non-ABC containing RAL or EGV based regimens
Drug: RAL or EGV based regimens without ABC
These are subjects who begin any other DTG based ARV regimen that will include DTG as monotherapy or two-drug regimens
Drug: Any other DTG based ARV regimen as monotherapy
ARV regimens containing DTG and ABC
DTG based ARV regimens that do not contain ABC
RAL or EGV based regimens containing ABC
RAL or EGV based ARV regimens that do not contain ABC
Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.
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.
Time frame: Up to 5 years
Number of subjects with hepatic dysfunction
Hepatic dysfunction will be indicated by liver chemistry tests
Time frame: Up to 5 years
No study locations are listed for this record.
Ran from Sep 2014 to primary completion in Dec 2019, 63 months.
Of 38 industry-sponsored observational studies under Infections, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's 63 months is above that.
Counting every sponsor, half of 297 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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