This website is designed for adults living with HIV and the healthcare professionals treating them to learn more about the global expanded access program (EAP) and named patient program (NPP) for dolutegravir. The dolutegravir EAP and NPP have been designed to provide access to ViiV Healthcare’s investigational integrase inhibitor, dolutegravir (DTG, S/GSK1349572) in an open-label programs to adults living with HIV who have documented raltegravir or elvitegravir resistance, who have limited treatment options, and who require DTG to construct a viable antiretroviral regimen for therapy.
Dolutegravir is an integrase strand transfer inhibitor (INSTI), for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age, approved by the Food and Drug Administration in August 2013 and by the European Medicines Agency in January 2014.
GlaxoSmithKline (GSK) and its operational partner PAREXEL are initiating the global EAP on behalf of ViiV Healthcare. Under special circumstances, where the potential benefits may outweigh the risks, new antiretroviral drugs can be made available before they are approved to patients with serious or life-threatening conditions who are unable to participate in ongoing clinical trials. Such access to investigational drugs is typically through limited access programs, often referred to as Expanded Access Programs (EAPs) and Named Patient Programs (NPP), and are based on specific safety and efficacy data from the Phase IIb clinical development program.
Who can participate in the dolutegravir EAP (ING114916) or NPP (ING115502) ?
Dolutegravir is available to adults living with HIV who (Note: Not all inclusion criteria are listed):
- Are male or female age 12 years or older (female patients of child-bearing potential should use every precaution to prevent pregnancy)
- Have documented raltegravir or elvitegravir resistance
- Are unable to construct a viable background regimen of anti-retroviral therapy with commercially available medications.
Dolutegravir EAP and NPP are not available to adults living with HIV who (Note: Not all exclusion criteria are listed):
- Have estimated creatinine clearance (CrCl) <30 mL/min
- Are pregnant or breastfeeding
- Have had a known or suspected allergic reaction to an integrase inhibitor
- Have an alanine aminotransferase (ALT) level >5 times the upper limit of normal (ULN)
- Have an ALT >3 times ULN and total bilirubin >1.5 times ULN
- Have evidence of severe hepatic impairment
- Are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial
- Have any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during screening of medical history or physical examination, which, in the opinion of the treating physician would interfere with safety or compliance
- Requires or is anticipated to require any of the prohibited concomitant therapy.
*Please note: country specific criteria may also apply.
The dolutegravir EAP is now open and accepting participants in Austria, Belgium, Canada, France, Germany, Italy and the US.
The dolutegravir NPP is now open and accepting participants in Argentina, Australia, Brasil, France, Luxembourg, the Netherlands, Portugal, Spain, Switzerland and the UK.
How to apply for participation
For adults living with HIV: Please discuss your possible participation with your healthcare professional. If the EAP or NPP are available in your country, check with your healthcare provider if he or she is a participating site. If not, your healthcare provider may contact PAREXEL for further details on how to access the program.
For healthcare professionals treating HIV: If you have an eligible patient(s), please contact PAREXEL at email@example.com for further details about the program. Please include your contact details (name, address, etc.) It is also necessary that you contact the PAREXEL mailbox for each patient enrolled.
What is dolutegravir?
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor under development as a treatment for HIV-1 infection. Phase III studies to assess the safety and efficacy of dolutegravir in antiretroviral naïve and experienced adults living with HIV are currently underway. The safety and efficacy of dolutegravir has not yet been fully established or thoroughly evaluated by regulatory agencies.