DEAP: Dolutegravir Expanded Access Study

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT01536873

Collaborator

GlaxoSmithKline (Industry)

200

Enrollment

Locations

51.3

Actual Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus HIV Infections	Drug: Dolutegravir	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 14, 2012

Actual Primary Completion Date :

Sep 23, 2016

Actual Study Completion Date :

Sep 23, 2016

Outcome Measures

Primary Outcome Measures

Expanded access [Not applicable for an expanded access study]
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

Secondary Outcome Measures

Assess adverse events [Not applicable for an expanded access study]
Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Phoenix	Arizona	United States	85012
2	GSK Investigational Site	San Francisco	California	United States	94115
3	GSK Investigational Site	Denver	Colorado	United States	80218
4	GSK Investigational Site	Fort Lauderdale	Florida	United States	33311
5	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
6	GSK Investigational Site	Orlando	Florida	United States	32803
7	GSK Investigational Site	Saint Petersburg	Florida	United States	33701
8	GSK Investigational Site	Vero Beach	Florida	United States	32960
9	GSK Investigational Site	Atlanta	Georgia	United States	30322
10	GSK Investigational Site	Chicago	Illinois	United States	60612
11	GSK Investigational Site	Chicago	Illinois	United States	60613
12	GSK Investigational Site	Chicago	Illinois	United States	60657
13	GSK Investigational Site	Topeka	Kansas	United States	66606
14	GSK Investigational Site	Saint Louis	Missouri	United States	63139
15	GSK Investigational Site	Omaha	Nebraska	United States	68198
16	GSK Investigational Site	Bronx	New York	United States	1057
17	GSK Investigational Site	New York	New York	United States	10011
18	GSK Investigational Site	Chapel Hill	North Carolina	United States	27599-7215
19	GSK Investigational Site	Lancaster	Pennsylvania	United States	17604
20	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
21	GSK Investigational Site	Austin	Texas	United States	78705
22	GSK Investigational Site	Dallas	Texas	United States	75204
23	GSK Investigational Site	Houston	Texas	United States	77004
24	GSK Investigational Site	Houston	Texas	United States	77098
25	GSK Investigational Site	Graz		Austria	A-8020
26	GSK Investigational Site	Linz		Austria	A-4020
27	GSK Investigational Site	Vienna		Austria	A-1140
28	GSK Investigational Site	Antwerpen		Belgium	2000
29	GSK Investigational Site	Brussels		Belgium	1000
30	GSK Investigational Site	Liege		Belgium	4000
31	GSK Investigational Site	Ipanema	Rio De Janeiro	Brazil	22410-906
32	GSK Investigational Site	Macae	Rio De Janeiro	Brazil	27910-210
33	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	2006
34	GSK Investigational Site	Sao Paulo	São Paulo	Brazil	04121-000
35	GSK Investigational Site	Fortaleza		Brazil	60455-610
36	GSK Investigational Site	Maceió		Brazil	57035-110
37	GSK Investigational Site	Ribeirão Preto		Brazil	14048-900
38	GSK Investigational Site	Rio de Janeiro		Brazil	20520-054
39	GSK Investigational Site	Rio de Janeiro		Brazil	20725-090
40	GSK Investigational Site	Rio de Janeiro		Brazil	21040-900
41	GSK Investigational Site	Sao Paulo		Brazil	01246-000
42	GSK Investigational Site	Vittoria		Brazil	29020-020
43	GSK Investigational Site	Vancouver	British Columbia	Canada	V6Z 1Y6
44	GSK Investigational Site	Hamilton	Ontario	Canada	L8N3Z5
45	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1K2
46	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4P9
47	GSK Investigational Site	Bordeaux cedex		France	33076
48	GSK Investigational Site	Le Kremlin-Bicêtre Cedex		France	94275
49	GSK Investigational Site	Marseille		France	13274
50	GSK Investigational Site	Nice		France	06202
51	GSK Investigational Site	Paris Cedex 10		France	75475
52	GSK Investigational Site	Paris Cedex 14		France	75679
53	GSK Investigational Site	Paris Cedex 18		France	75877
54	GSK Investigational Site	Paris Cedex 20		France	75970
55	GSK Investigational Site	Paris		France	75012
56	GSK Investigational Site	Paris		France	75013
57	GSK Investigational Site	Paris		France	75015
58	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
59	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg	Germany	70197
60	GSK Investigational Site	Frankfurt	Hessen	Germany	60596
61	GSK Investigational Site	Osnabrueck	Niedersachsen	Germany	49090
62	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53127
63	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50674
64	GSK Investigational Site	Luebeck	Schleswig-Holstein	Germany	23538
65	GSK Investigational Site	Mannheim		Germany	68161
66	GSK Investigational Site	Genova	Liguria	Italy	16128
67	GSK Investigational Site	Genova	Liguria	Italy	16132
68	GSK Investigational Site	Milano	Lombardia	Italy	20127
69	GSK Investigational Site	Pavia	Lombardia	Italy	27100
70	GSK Investigational Site	Bagno A Ripoli (FI)	Toscana	Italy	50011
71	GSK Investigational Site	Firenze	Toscana	Italy	50134
72	GSK Investigational Site	Modena		Italy	41124
73	GSK Investigational Site	Venezia		Italy	30122
74	GSK Investigational Site	Szczecin		Poland	71-455