PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)

NCT ID: NCT03327740

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-12-31

Brief 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. 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.

Conditions

Infection, Human Immunodeficiency Virus I

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects on DTG based ARV with ABC

These are subjects who begin a DTG based ARV regimen that includes ABC

DTG based ARV regimen with ABC

Intervention Type: DRUG

ARV regimens containing DTG and 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

DTG based ARV regimen without ABC

Intervention Type: DRUG

DTG based ARV regimens that do not contain 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

RAL or EGV based ARV regimens with ABC

Intervention Type: DRUG

RAL or EGV based regimens containing ABC

Subjects on other integrase inhibitor based regimen but no ABC

These are subjects that start non-ABC containing RAL or EGV based regimens

RAL or EGV based regimens without ABC

Intervention Type: DRUG

RAL or EGV based ARV regimens that do not contain 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

Any other DTG based ARV regimen as monotherapy

Intervention Type: DRUG

Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.

Interventions

DTG based ARV regimen with ABC

ARV regimens containing DTG and ABC

Intervention Type: DRUG

DTG based ARV regimen without ABC

DTG based ARV regimens that do not contain ABC

Intervention Type: DRUG

RAL or EGV based ARV regimens with ABC

RAL or EGV based regimens containing ABC

Intervention Type: DRUG

RAL or EGV based regimens without ABC

RAL or EGV based ARV regimens that do not contain ABC

Intervention Type: DRUG

Any other DTG based ARV regimen as monotherapy

Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• New users of DTG or users of other integrase inhibitor regimens (RAL and EGV)

Exclusion Criteria

• None

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Other Identifiers

PRJ2203

Identifier Type: OTHER

Identifier Source: secondary_id

201177

Identifier Type: -

Identifier Source: org_study_id