Skip to main content
OpenTrials
Completed

NCT Number: NCT01536873

Dolutegravir Expanded Access Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Graz, Austria

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Treatment and study plan

Dolutegravir

Drug

Eligible patients will receive DTG 50 mg given orally BID

Primary outcomes

  1. Expanded access

    Time frame: 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 outcomes

  1. Assess adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: DEAP

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2012
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.