Dolutegravir Expanded Access Study (DEAP)

ViiV Healthcare

Status: Completed

Conditions: Infection, Human Immunodeficiency Virus; HIV Infections

Treatments: Drug: Dolutegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536873

114916

2011-001646-16 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)