Dolutegravir Expanded Access Study

Not Applicable

Completed

• Conditions: Infection, Human Immunodeficiency Virus; HIV Infections

• Registration Number: NCT01536873
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Study Start: 2012-06-14
• Primary Completion: 2016-09-23
• Study Completion: 2016-09-23
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇱 Szczecin, Poland