An interventional study of Dolutegravir in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by ViiV Healthcare. Completed at 74 sites in 9 countries. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by ViiV Healthcare · Not applicable, Interventional, and Treatment
ING114916 is an open-label, multi-center, expanded access (EAP) study
ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.
The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Eligible patients will receive DTG 50 mg given orally BID
Expanded access
To to provide access in an open label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable ARV regimen for therapy
Time frame: Not applicable for an expanded access study
Assess adverse events
Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID
Time frame: Not applicable for an expanded access study
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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ViiV Healthcare