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NCT01536873 Clinical Trial

Dolutegravir Expanded Access Study

HIV Infections Clinical Trial

— DEAP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01536873
Other study ID # 114916
Secondary ID 2011-001646-16
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2012
Est. completion date September 23, 2016

Study information
Verified date September 2020
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 23, 2016
Est. primary completion date September 23, 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years to 99 Years
Eligibility Inclusion Criteria:

1. 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.

-

Exclusion Criteria:

1. Creatnine clearance < 30ml/min via Cockcroft-Gault method

2. Females who are pregnant and/or breastfeeding

3. Patients with known integrase allergic reaction

4. ALT > 5 times the ULN within one month of treatment initiation

5. ALT > 3 times ULN and total bilirubin >1.5 times ULN

6. Evidence of severe hepatic impairment

7. Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study

8. Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dolutegravir
Eligible patients will receive DTG 50 mg given orally BID

Locations
Country Name City State
Austria GSK Investigational Site Graz
Austria GSK Investigational Site Linz
Austria GSK Investigational Site Vienna
Belgium GSK Investigational Site Antwerpen
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Liege
Brazil GSK Investigational Site Fortaleza
Brazil GSK Investigational Site Ipanema Rio De Janeiro
Brazil GSK Investigational Site Macae Rio De Janeiro
Brazil GSK Investigational Site Maceió
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Ribeirão Preto
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Sao Paulo
Brazil GSK Investigational Site Sao Paulo São Paulo
Brazil GSK Investigational Site Vittoria
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Vancouver British Columbia
France GSK Investigational Site Bordeaux cedex
France GSK Investigational Site Le Kremlin-Bicêtre Cedex
France GSK Investigational Site Marseille
France GSK Investigational Site Nice
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris Cedex 10
France GSK Investigational Site Paris Cedex 14
France GSK Investigational Site Paris Cedex 18
France GSK Investigational Site Paris Cedex 20
Germany GSK Investigational Site Bonn Nordrhein-Westfalen
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Freiburg Baden-Wuerttemberg
Germany GSK Investigational Site Koeln Nordrhein-Westfalen
Germany GSK Investigational Site Luebeck Schleswig-Holstein
Germany GSK Investigational Site Mannheim
Germany GSK Investigational Site Osnabrueck Niedersachsen
Germany GSK Investigational Site Stuttgart Baden-Wuerttemberg
Italy GSK Investigational Site Bagno A Ripoli (FI) Toscana
Italy GSK Investigational Site Firenze Toscana
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena
Italy GSK Investigational Site Pavia Lombardia
Italy GSK Investigational Site Venezia
Poland GSK Investigational Site Szczecin
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Chapel Hill North Carolina
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 Dallas Texas
United States 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 Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Lancaster Pennsylvania
United States GSK Investigational Site New York New York
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site Saint Petersburg Florida
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Topeka Kansas
United States GSK Investigational Site Vero Beach Florida

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Not applicable for an expanded access study
Secondary Assess adverse events Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID Not applicable for an expanded access study
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