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

ViiV Healthcare

Status and phase: Completed; Phase 3

Conditions: Infection, Human Immunodeficiency Virus I

Treatments: Other: GSK1349572 Placebo; Drug: raltegravir; Drug: GSK1349572 (dolutegravir); Other: TDF/FTC; Other: raltegravir Placebo; Other: ABC/3TC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227824

113086

Details and patient eligibility

About

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.

Full 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

Enrollment: 828 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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828 participants in 2 patient groups

GSK1349572 (N=~394)

Experimental group

Description:

GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily

Treatment:

Other: GSK1349572 Placebo

Other: ABC/3TC

Drug: GSK1349572 (dolutegravir)

Other: TDF/FTC

raltegravir (N=~394)

Active Comparator group

Description:

raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily

Treatment:

Other: raltegravir Placebo

Other: ABC/3TC

Drug: raltegravir

Other: TDF/FTC