Clinical trial NCT01231516
Conditions: Infection, Human Immunodeficiency Virus HIV Infections
Keywords: ART-experienced Integrase inhibitor Raltegravir GSK1349572 Integrase inhibitor naive
Sponsor: ViiV Healthcare
Start date: 2010-10-26; Completion date: 2021-02-02
Enrollment: 724 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

Detailed description:
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

Subjects must have documented genotypic or phenotypic resistance to at least one member of each of at least two antiretroviral therapy (ART) drug classes \[nucleoside/nucleotide reverse transcriptase inhibitor (N\[t\]RTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), fusion inhibitor (T20), or entry inhibitor (chemokine receptor 5 \[CCR5\] antagonist)\].

The primary analysis will take place after the last subject completes 48 weeks on therapy. An additional data cut and analysis will be conducted after the last subject completes 24 weeks on therapy.

Subjects randomized to GSK1349572 who successfully complete Week 48 will continue to received GSK1349572 until either it is locally available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

ViiV Healthcare is the sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Arms: arm 1: Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily. arm 2: Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Interventions: intervention 1: GSK1349572 intervention 2: Raltegravir intervention 3: GSK1349572 Placebo intervention 4: Raltegravir Placebo
Intervention descriptions: intervention 1: 50mg once daily intervention 2: 400mg twice daily intervention 3: Inactive placebo tablet once daily intervention 4: Inactive placebo tablet twice daily

Protocol documents: