NCT01536873

Dolutegravir Expanded Access Study

A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

ING114916 is an open-label, multi-center, expanded access (EAP) study

Detailed description

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.

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections

Interventions

Type	Name	Description
DRUG	Dolutegravir	Eligible patients will receive DTG 50 mg given orally BID

Timeline

• Start date: 2012-06-14
• Primary completion: 2016-09-23
• Completion: 2016-09-23
• First posted: 2012-02-22
• Last updated: 2020-09-30

Locations

74 sites across 9 countries: United States, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Poland