Dolutegravir Expanded Access Study

ViiV Healthcare200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Infection, Human Immunodeficiency Virus HIV Infections

Interventions

DolutegravirDRUG

Eligible patients will receive DTG 50 mg given orally BID

Eligibility

Sex: ALLMin age: 12 YearsMax age: 99 Years

Medical Language ↔ Plain English

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 -

Locations (74)

Outcomes

Primary Outcomes

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

Time frame: Not applicable for an expanded access study

Secondary Outcomes

Assess adverse events

Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID

Time frame: Not applicable for an expanded access study

Data from ClinicalTrials.gov

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GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

San Francisco, California, 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

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

...and 64 more locations