A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
This study is ongoing, but not recruiting participants.
Sponsor:
ViiV Healthcare
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01263015
First received: December 16, 2010
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Infection, Human Immunodeficiency Virus I |
Drug: Dolutegravir Drug: Atripla Drug: Abacavir/Lamivudine Drug: Abacavir/Lamivudine Placebo Drug: Dolutegravir placebo Drug: Atripla placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- The primary efficacy endpoint is the proportion of subjects achieving and maintaining confirmed HIV-1 RNA less than 50 copies/mL through Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the efficacy of the treatment arms over time using proportions of subjects maintaining plasma HIV-1 RNA <50copies/mL to Week 96 as well as change from baseline in HIV-1 RNA and increases in CD4+ cell counts [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]
- To evaluate the number of participants with clinical or laboratory adverse events as a measure of safety and tolerability of the two treatment arms [ Time Frame: 48 and 96 Weeks ] [ Designated as safety issue: No ]
- To assess the development of viral resistance in subjects experiencing virological failure. [ Time Frame: 48 and 96 Weeks ] [ Designated as safety issue: No ]
- To evaluate the incidence of HIV-associated conditions. [ Time Frame: 48 and 96 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 788 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dolutegravir (N=~394):
Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily
|
Drug: Dolutegravir
Dolutegravir (also known as GSK1349572) 50 mg taken once daily
Drug: Abacavir/Lamivudine
taken once daily; also known as EPZICOM
Drug: Atripla placebo
matching placebo taken once daily on an empty stomach
|
|
Active Comparator: Atripla (N=~394):
Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily
|
Drug: Atripla
Atripla once daily on an empty stomach
Drug: Abacavir/Lamivudine Placebo
matching placebo taken once daily
Drug: Dolutegravir placebo
matching placebo taken once daily
|
Detailed Description:
ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:
GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)
OR
Atripla once daily (approximately 394 subjects)
Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Screening plasma HIV-1 RNA ≥1000 c/mL
- Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
- Ability to understand and sign a written informed consent form
- Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
- Age equal to or greater than 18 years
- A negative HLAB*5701 allele assessment
Exclusion Criteria:
- Women who are pregnant or breastfeeding;
- Active Center for Disease and Prevention Control (CDC) Category C disease
- Hepatic impairment
- HBV co-infection
- Anticipated need for HCV therapy during the study
- Allergy or intolerance to the study drugs or their components or drugs of their class
- Malignancy within the past 5 years
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
- Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
- Primary viral resistance in the Screening result
- Verified Grade 4 laboratory abnormality
- ALT >5 xULN
- ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin);
- Estimated creatinine clearance <50 mL/min
- Recent history (≤3 months) of upper or lower gastrointestinal bleed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263015
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| United States, Alabama | |
| GSK Investigational Site | |
| Hobson City, Alabama, United States, 36201 | |
| United States, Arkansas | |
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| Little Rock, Arkansas, United States, 72207 | |
| United States, California | |
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| Bakersfield, California, United States, 93301 | |
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| Beverly Hills, California, United States, 90211 | |
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| Long Beach, California, United States, 90813 | |
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| Los Angeles, California, United States, 90069 | |
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| Oakland, California, United States, 94602 | |
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| San Diego, California, United States, 92103 | |
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| San Francisco, California, United States, 94109 | |
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| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
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| Denver, Colorado, United States, 80209 | |
| United States, District of Columbia | |
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| Washington, District of Columbia, United States, 20007 | |
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| Washington, District of Columbia, United States, 20037 | |
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| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
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| Fort Lauderdale, Florida, United States, 33316 | |
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| Fort Pierce, Florida, United States, 34982 | |
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| Miami Beach, Florida, United States, 33139 | |
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| Orlando, Florida, United States, 32804 | |
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| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
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| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
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| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
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| Baltimore, Maryland, United States, 21201 | |
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| Springfield, Massachusetts, United States, 01105 | |
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| Minneapolis, Minnesota, United States, 55404 | |
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| Minneapolis, Minnesota, United States, 55415 | |
| United States, Nebraska | |
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| Omaha, Nebraska, United States, 68106 | |
| United States, Nevada | |
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| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
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| Newark, New Jersey, United States, 07102 | |
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| Bronx, New York, United States, 10461 | |
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| New York, New York, United States, 10065 | |
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| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
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| Chapel Hill, North Carolina, United States, 27514 | |
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| Charlotte, North Carolina, United States, 28209 | |
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| Charlotte, North Carolina, United States, 28207 | |
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| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
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| Cincinnati, Ohio, United States, 45267 | |
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| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
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| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
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| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
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| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
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| Dallas, Texas, United States, 75204 | |
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| Dallas, Texas, United States, 75215 | |
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| Dallas, Texas, United States, 75246 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Houston, Texas, United States, 77030 | |
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| Longview, Texas, United States, 75605 | |
| United States, Utah | |
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| Salt Lake City, Utah, United States, 84102 | |
| Australia, New South Wales | |
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| Darlinghurst, Sydney, New South Wales, Australia, 2010 | |
| Australia, Victoria | |
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| Carlton, Victoria, Australia, 3053 | |
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| North Fitzroy, Victoria, Australia, 3078 | |
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| Prahran, Victoria, Australia, 3181 | |
| Belgium | |
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| Antwerpen, Belgium, 2000 | |
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| Brussels, Belgium, 1000 | |
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| Gent, Belgium, 9000 | |
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| Liege, Belgium, 4000 | |
| Canada, Alberta | |
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| Calgary, Alberta, Canada, T2R 0X7 | |
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| Vancouver, British Columbia, Canada, V6Z 2T1 | |
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| Vancouver, British Columbia, Canada, V6Z 2C7 | |
| Canada, Manitoba | |
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| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Ontario | |
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| Toronto, Ontario, Canada, M5G 2N2 | |
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| Toronto, Ontario, Canada, M5G 1K2 | |
| Canada, Quebec | |
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| Montreal, Quebec, Canada, H3A 1T1 | |
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| Montreal, Quebec, Canada, H2L 4P9 | |
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| Montreal, Quebec, Canada, H3G 1A4 | |
| Denmark | |
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| Koebenhavn, Denmark, DK-2100 | |
| France | |
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| Nice, France, 06202 | |
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| Orléans Cedex 2, France, 45067 | |
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| Paris Cedex 20, France, 75970 | |
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| Saint Denis Cedex 01, France, 93205 | |
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| Strasbourg cedex, France, 67091 | |
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| Tourcoing cedex, France, 59208 | |
| Germany | |
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| Stuttgart, Baden-Wuerttemberg, Germany, 70197 | |
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| Muenchen, Bayern, Germany, 80335 | |
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| Frankfurt, Hessen, Germany, 60590 | |
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| Frankfurt, Hessen, Germany, 60311 | |
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| Hannover, Niedersachsen, Germany, 30159 | |
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| Duesseldorf, Nordrhein-Westfalen, Germany, 40225 | |
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| Essen, Nordrhein-Westfalen, Germany, 45122 | |
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| Berlin, Germany, 13353 | |
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| Berlin, Germany, 12157 | |
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| Hamburg, Germany, 20146 | |
| Italy | |
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| Ravenna, Emilia-Romagna, Italy, 48121 | |
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| Roma, Lazio, Italy, 00149 | |
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| Genova, Liguria, Italy, 16132 | |
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| Bergamo, Lombardia, Italy, 24127 | |
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| Milano, Lombardia, Italy, 20127 | |
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| Bagno a Ripoli (FI), Toscana, Italy, 50011 | |
| Netherlands | |
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| Rotterdam, Netherlands, 3079 DZ | |
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| Rotterdam, Netherlands, 3015 CE | |
| Romania | |
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| Bucharest, Romania, 021105 | |
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| Bucharest, Romania, 030303 | |
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| Constanta, Romania, 900708 | |
| Spain | |
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| (Móstoles) Madrid, Spain, 28935 | |
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| Alcala de Henares, Spain, 28805 | |
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| Alicante, Spain, 03010 | |
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| Badalona, Spain, 08916 | |
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| Barcelona, Spain, 08025 | |
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| Barcelona, Spain, 08907 | |
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| Barcelona, Spain, 08035 | |
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| Basurto/Bilbao, Spain, 48013 | |
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| Elche (Alicante), Spain, 03202 | |
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| Granada, Spain, 18014 | |
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| Granollers (Barcelona), Spain, 08400 | |
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| La Laguna (Santa Cruz de Tenerife), Spain, 38320 | |
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| Logroño, Spain, 26006 | |
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| Madrid, Spain, 28029 | |
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| Madrid, Spain, 28007 | |
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| Madrid, Spain, 28046 | |
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| Madrid, Spain, 28034 | |
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| Madrid, Spain, 28006 | |
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| Madrid, Spain, 28911 | |
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| Madrid, Spain, 28040 | |
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| Madrid, Spain, 28041 | |
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| Marid, Spain, 28040 | |
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| Murcia, Spain | |
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| Málaga, Spain, 29010 | |
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| Oviedo, Spain, 33006 | |
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| Palma de Mallorca, Spain, 07010 | |
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| San Sebastián, Spain, 20014 | |
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| Santiago de Compostela, Spain, 15706 | |
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| Sevilla, Spain, 41013 | |
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| Valencia, Spain, 46015 | |
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| Valencia, Spain, 46010 | |
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| Valencia, Spain, 46026 | |
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| Vigo ( Pontevedra), Spain, 36204 | |
| United Kingdom | |
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| Woolwich, London, London, United Kingdom, SE18 4QH | |
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| Birmingham, United Kingdom, B9 5SS | |
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| London, United Kingdom, SW10 9TH | |
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| London, United Kingdom, NW3 2QG | |
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| London, United Kingdom, SE1 7EH | |
| GSK Investigational Site | |
| Tooting, London, United Kingdom, SW17 0QT | |
Sponsors and Collaborators
ViiV Healthcare
Shionogi
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | ViiV Healthcare |
More Information
No publications provided
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01263015 History of Changes |
| Other Study ID Numbers: | 114467 |
| Study First Received: | December 16, 2010 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Spain: Agencia Espanola de Medicamentos y Productos Sanitarios Italy: Comitato Etico Fondazione Centro San Raffaele del Monte Tabor - Via Olgettina, 60 - 20132 Milano Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Belgium: Federal Agency for Medicines and Health Products United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Hungary: Országos Gyógyszerészeti Intézet South Africa: Medicines Control Council Germany: Bundesinstitut für Arzneimittel und Medizinprodukte Romania: National Medicines Agency Denmark: Danish Medicines Agency France: Agence Française de Sécurité Sanitaire des Produits de Santé Canada: Health Canada Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Australia: Therapeutic Goods Administration |
Keywords provided by ViiV Healthcare:
|
GSK1349572 Abacavir/Lamivudine Treatment-naive HIV Infection |
Dolutegravir integrase inhibitor Atripla |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Lamivudine Abacavir |
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination Integrase Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013