Infection, Human Immunodeficiency VirusDEAPNCT01536873
Dolutegravir Expanded Access Study
A study testing Dolutegravir in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 74 sites in 9 countries.
Trial summary
ING114916 is an open-label, multi-center, expanded access (EAP) study Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Infection, Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- Dolutegravir
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 14 Jun 2012to 23 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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 -
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
United States24 sites
GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7215
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60613
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Dallas, Texas, 75204
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Fort Lauderdale, Florida, 33311
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Houston, Texas, 77098
GSK Investigational Site
Lancaster, Pennsylvania, 17604
GSK Investigational Site
New York, New York, 10011
GSK Investigational Site
Omaha, Nebraska, 68198
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Phoenix, Arizona, 85012
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
St Louis, Missouri, 63139
GSK Investigational Site
St. Petersburg, Florida, 33701
GSK Investigational Site
The Bronx, New York, 1057
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Vero Beach, Florida, 32960
Brazil12 sites
GSK Investigational Site
Fortaleza, 60455-610
GSK Investigational Site
Ipanema, Rio de Janeiro, 22410-906
GSK Investigational Site
Macaé, Rio de Janeiro, 27910-210
GSK Investigational Site
Maceió, 57035-110
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 2006
GSK Investigational Site
Ribeirão Preto, 14048-900
GSK Investigational Site
Rio de Janeiro, 20520-054
GSK Investigational Site
Rio de Janeiro, 20725-090
GSK Investigational Site
Rio de Janeiro, 21040-900
GSK Investigational Site
São Paulo, São Paulo, 04121-000
GSK Investigational Site
São Paulo, 01246-000
GSK Investigational Site
Vittoria, 29020-020
France11 sites
GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Le Kremlin-Bicêtre, 94275
GSK Investigational Site
Marseille, 13274
GSK Investigational Site
Nice, 06202
GSK Investigational Site
Paris, 75012
GSK Investigational Site
Paris, 75013
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Paris, 75877
GSK Investigational Site
Paris, 75970
Germany8 sites
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23538
GSK Investigational Site
Mannheim, 68161
GSK Investigational Site
Osnabrück, Lower Saxony, 49090
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70197
Italy8 sites
GSK Investigational Site
Bagno A Ripoli (FI), Tuscany, 50011
GSK Investigational Site
Florence, Tuscany, 50134
GSK Investigational Site
Genoa, Liguria, 16128
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Modena, 41124
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Venezia, 30122
Canada4 sites
GSK Investigational Site
Hamilton, Ontario, L8N3Z5
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Toronto, Ontario, M5G 1K2
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Austria3 sites
GSK Investigational Site
Graz, A-8020
GSK Investigational Site
Linz, A-4020
GSK Investigational Site
Vienna, A-1140
Belgium3 sites
GSK Investigational Site
Antwerp, 2000
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Liège, 4000
About this study
Official title: A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance
ING114916 is an open-label, multi-center, expanded access (EAP) study
Read the 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.
- Being tested
- Dolutegravir
- Keywords
- treatment experienced patients, Integrase resistance
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Eligible patients will receive DTG 50 mg given orally BID
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Not applicable for an expanded access study
Secondary outcomes (1)
Assess adverse events
Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID
Measured: Not applicable for an expanded access study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study start14 Jun 2012
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536873
- Sponsor's protocol ID
- 114916
- Other IDs
- 2011-001646-16
- Acronym
- DEAP
- Status last verified
- Sep 2020
- First submitted
- 16 Feb 2012
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance
- ClinicalTrials.gov ID
- NCT01536873
- Acronym / sponsor ID
- DEAP / 114916
- Keywords
- treatment experienced patients, Integrase resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 14 Jun 2012 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DolutegravirEligible patients will receive DTG 50 mg given orally BID | Drug | – |
Primary outcome
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
1 secondary outcome
Assess adverse events
Time frame: Not applicable for an expanded access study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dolutegravir in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 74 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Brazil, France, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded access (time frame: Not applicable for an expanded access study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.