A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.
18 Years
N/A
Both
Infection, Human Immunodeficiency Virus
Trial Information
A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.
ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral
activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with
historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100
subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen
for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or
phenotypic resistance to at least one compound in two or more of the other approved classes
of ART but must also be able to include at least one fully active drug in the OBR to be
started Day 8. The first data cut will take place after the (approximate) 100th subject
enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100
subjects have been recruited. All subjects who successfully complete 24 weeks of treatment
will continue to have access to DTG until it is locally available as long as they continue
to derive clinical benefit.
ViiV Healthcare is the sponsor of this study.
Inclusion Criteria:
- Screening plasma HIV-1 RNA ≥500 copies/mL
- ART-experienced, INI-experienced, DTG naïve
- Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen
- The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time
point of virological failure on RAL or ELV
- Documented resistance to at least one drug from each of three or more of all approved
classes of ART
- Be able to receive at least one fully active drug as part of the OBR from Day 8
- Women capable of becoming pregnant must use appropriate contraception during the
study (as defined by the protocol)
- Willing and able to understand and provide signed and dated written informed consent
prior to Screening.
Exclusion Criteria:
- Women who are pregnant or breast feeding
- An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not
requiring systemic therapy or CD4+ <200c/mm3)
- Moderate to severe hepatic impairment as defined by Child-Pugh classification
- Anticipated need for HCV therapy during the first 24 weeks of the study
- Recent history of any upper or lower gastrointestinal bleed, with the exception of
anal or rectal bleeding
- Allergy or intolerance to the study drugs or their components or drugs of their class
- Malignancy within the past 6 months
- Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any
immunomodulator within 28 days of Screening
- Treatment with any agent, other than licensed ART, with documented activity against
HIV-1 in vitro within 28 days of first dose of investigational product
- Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day
1(etravirine may be used if coadministered with lopinivir/ritonavir or
darunavir/ritonavir)
- Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within
28 days prior to Screening
- Verified Grade 4 laboratory abnormality at Screening
- ALT> 5 times the upper limit of normal (ULN) at Screening
- ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean change from Baseline in Plasma HIV-1 RNA at Day 8
Outcome Description:
Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.
Outcome Time Frame:
Baseline and Day 8
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
ViiV Healthcare
Authority:
Italy: AIFA - Italian Ministry of Health
Study ID:
112574
NCT ID:
NCT01328041
Start Date:
May 2011
Completion Date:
January 2016
Related Keywords:
- Infection, Human Immunodeficiency Virus
- GSK1349572
- resistance to raltegravir or elvitegravir
- Integrase inhibitor
- ART-experienced
- dolutegravir
- Acquired Immunodeficiency Syndrome
- HIV Infections
- Immunologic Deficiency Syndromes
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | New Orleans, Louisiana 70112 |
| GSK Investigational Site | Springfield, Massachusetts 01107 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Savannah, Georgia 31405 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Salem, Virginia 24153 |
| GSK Investigational Site | New York, New York 10021 |
| GSK Investigational Site | Hartford, Connecticut 06106 |
| GSK Investigational Site | Washington, District of Columbia 20307-5001 |
| GSK Investigational Site | Hattiesburg, Mississippi 39401 |
| GSK Investigational Site | Cranston, Rhode Island 02920 |
