Dolutegravir Expanded Access Study

Completed · Not applicable

Conditions studied: Infection, Human Immunodeficiency Virus, HIV Infections

In brief

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

Key facts

Study ID

NCT01536873

Run by

ViiV Healthcare

People needed

200

Starts

2012-06-14

Expected to finish

2016-09-23

Last updated by the study team

2020-09-30

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects greater than 18 years of age 2. Documented HIV-1 RNA >/= 400 c/mL 3. Documented raltegravir or elvitegravir resistance 4. Inability to construct a viable background ART regimen with commercially available medications.

You may not qualify if…

• Creatnine clearance < 30ml/min via Cockcroft-Gault method
• Females who are pregnant and/or breastfeeding
• Patients with known integrase allergic reaction
• ALT > 5 times the ULN within one month of treatment initiation
• ALT > 3 times ULN and total bilirubin >1.5 times ULN
• Evidence of severe hepatic impairment
• Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study
• Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -

Where it is running

• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — Vero Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Lancaster, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Graz, Austria
• GSK Investigational Site — Linz, Austria
• GSK Investigational Site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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