Dolutegravir Expanded Access Study

Study Overview
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Brief Summary
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ING114916 is an open-label, multi-center, expanded access (EAP) study

Detailed Description
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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.

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

Conditions
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Infection, Human Immunodeficiency Virus, HIV Infections

Intervention / Treatment
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* Drug: Dolutegravir


Participation Criteria
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Eligibility Criteria
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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: 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 -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dolutegravir|Eligible patients will receive DTG 50 mg given orally BID|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment experienced patients, Integrase resistance