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A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily (SPRING-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01227824
First received: October 14, 2010
Last updated: May 2, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus I
 Drug: GSK1349572
Drug: raltegravir
Other: Placebo
Other: ABC/3TC
Other: TDF/FTC
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

Resource links provided by NLM:

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 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 evaluate the pharmacokinetics of GSK1349572 over time as measured by Area Under the Curve, maximum and minimum concentrations of GSK1349572. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • 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 ]

Enrollment: 788
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1349572 (N=~394)
GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily
 Drug: GSK1349572
GSK1349572 50 mg or matching placebo taken once daily with or without food
Other: Placebo
raltegravir placebo twice daily or GSK1349572 placebo once daily
Other: ABC/3TC
NRTI background therapy once daily
Other: TDF/FTC
NRTI background therapy once daily
Active Comparator: raltegravir (N=~394)
raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily
 Drug: raltegravir
raltegravir 400mg or matching placebo taken twice daily
Other: Placebo
raltegravir placebo twice daily or GSK1349572 placebo once daily
Other: ABC/3TC
NRTI background therapy once daily
Other: TDF/FTC
NRTI background therapy once daily

Detailed Description:

ING113086 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:

  1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

    OR

  2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

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 through the study until either it is locally available, as long as they continue to derive clinical benefit.

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

Exclusion Criteria:

  • Women who are pregnant or breastfeeding;
  • Active Center for Disease and Prevention Control (CDC) Category C disease
  • Moderate to severe hepatic impairment
  • 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: NCT01227824

  Show 91 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Shionogi
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided by ViiV Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01227824     History of Changes
Other Study ID Numbers: 113086
Study First Received: October 14, 2010
Last Updated: May 2, 2013
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
Australia: Human Research Ethics Committee
Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation
United States: Food and Drug Administration
Russia: Russian Ministry of Health
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Europe: European Medicines Agency

Keywords provided by ViiV Healthcare:
integrase inhibitor
HIV Infection
raltegravir
GSK1349572

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
 Reverse Transcriptase Inhibitors
Integrase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013