Dolutegravir Expanded Access Study

NCT01536873 | Completed

• 2 other identifiers: 1149162011-001646-16
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 74

Brief Summary

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

Conditions

Infection, Human Immunodeficiency Virus; HIV Infections

Keywords

treatment experienced patients; Integrase resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess adverse events

  Not applicable for an expanded access study

Interventions

Dolutegravir DRUG

Eligible patients will receive DTG 50 mg given orally BID

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 -

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (74)

GSK Investigational Site

Phoenix, Arizona, 85012, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Denver, Colorado, 80218, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33311, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Vero Beach, Florida, 32960, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30322, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Topeka, Kansas, 66606, United States

Location

GSK Investigational Site

St Louis, Missouri, 63139, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

New York, New York, 10011, United States

Location

GSK Investigational Site

The Bronx, New York, 1057, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599-7215, United States

Location

GSK Investigational Site

Lancaster, Pennsylvania, 17604, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Dallas, Texas, 75204, United States

Location

GSK Investigational Site

Houston, Texas, 77004, United States

Location

GSK Investigational Site

Houston, Texas, 77098, United States

Location

GSK Investigational Site

Graz, A-8020, Austria

Location

GSK Investigational Site

Linz, A-4020, Austria

Location

GSK Investigational Site

Vienna, A-1140, Austria

Location

GSK Investigational Site

Antwerp, 2000, Belgium

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Ipanema, Rio de Janeiro, 22410-906, Brazil

Location

GSK Investigational Site

Macaé, Rio de Janeiro, 27910-210, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 2006, Brazil

Location

GSK Investigational Site

São Paulo, São Paulo, 04121-000, Brazil

Location

GSK Investigational Site

Fortaleza, 60455-610, Brazil

Location

GSK Investigational Site

Maceió, 57035-110, Brazil

Location

GSK Investigational Site

Ribeirão Preto, 14048-900, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 20520-054, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 20725-090, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 21040-900, Brazil

Location

GSK Investigational Site

São Paulo, 01246-000, Brazil

Location

GSK Investigational Site

Vittoria, 29020-020, Brazil

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N3Z5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Marseille, 13274, France

Location

GSK Investigational Site

Nice, 06202, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Paris, 75013, France

Location

GSK Investigational Site

Paris, 75015, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Paris, 75877, France

Location

GSK Investigational Site

Paris, 75970, France

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70197, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Osnabrück, Lower Saxony, 49090, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50674, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23538, Germany

Location

GSK Investigational Site

Mannheim, 68161, Germany

Location

GSK Investigational Site

Genoa, Liguria, 16128, Italy

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Bagno A Ripoli (FI), Tuscany, 50011, Italy

Location

GSK Investigational Site

Florence, Tuscany, 50134, Italy

Location

GSK Investigational Site

Modena, 41124, Italy

Location

GSK Investigational Site

Venezia, 30122, Italy

Location

GSK Investigational Site

Szczecin, 71-455, Poland

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: June 14, 2012
• Primary Completion: September 23, 2016
• Study Completion: September 23, 2016
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

CA (4); IT (8); AU (3); US (24); PL (1); DE (8); BE (3); BR (12); FR (11)