Dolutegravir Expanded Access Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01536873

Acronym

DEAP

Enrollment

200

Registered

2012-02-22

Start date

2012-06-14

Completion date

2016-09-23

Last updated

2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Infection, Human Immunodeficiency Virus

Keywords

treatment experienced patients, Integrase resistance

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.

Interventions

DRUGDolutegravir

Eligible patients will receive DTG 50 mg given orally BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 99 Years

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Austria, Belgium, Brazil, Canada, France, Germany, Italy, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026