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Multicenter, Randomized, Doub...

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Last Updated: 2016-05-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

724 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

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Detailed Description

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The background regimen will be constructed by the investigator based on viral resistance testing. The fully active PI will be defined by phenotypic resistance analysis. For phenotypic susceptibility, fully active is defined as being below the lower clinical or biological cutoff. Participants are required to take their ritonavir dose based on the dosing schedule indicated in the prescribing information for the PI; no additional ritonavir is required to be taken with EVG. No other marketed PIs are allowed as part of the background regimen due to unknown drug interactions.

The second agent can be one nucleoside or nucleotide reverse transcriptase inhibitor (NRTI), etravirine, maraviroc, or T-20. However, the second agent must not include an integrase inhibitor; the nonnucleoside reverse transcriptase inhibitors efavirenz, nevirapine, or delavirdine (due to unknown drug interactions); or the fixed-dose combination therapies Atripla® or Trizivir® (abacavir sulfate/lamivudine/zidovudine). The second agent may or may not be fully active (except in Spain, where participants have to receive a fully active second agent, as requested by the Spanish regulatory agency).

If the M184V/I reverse transcriptase (RT) mutation is present on the screening genotype report and an NRTI is used as the second agent, then either FTC or LAM may be added as a third agent in the background regimen to maintain the M184V/I mutation. In this situation only, the fixed-dose combination therapies Combivir®, Truvada®, or Epzicom/Kivexa® may be prescribed as the combined second and third agents of the background regimen.

After Week 96, participants will continue to take their blinded study drug and attend visits until treatment assignments are unblinded, at which point they will be given the option to participate in an open-label EVG extension phase of the study.

Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Elvitegravir

EVG 85 mg or 150 mg + RAL placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase.

Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their background regimen will receive EVG 85 mg; all other participants will receive EVG 150 mg.

Group Type EXPERIMENTAL

Elvitegravir

Intervention Type DRUG

Elvitegravir (EVG) tablet administered orally once daily with food

RAL placebo

Intervention Type DRUG

RAL placebo administered orally twice daily.

Background regimen

Intervention Type DRUG

Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.

Raltegravir

RAL 800 mg (400 mg twice daily) + EVG placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase.

Participants receiving LPV/r or ATV/r as part of their background regimen in the Open-Label Phase will receive EVG 85 mg; all other participants will receive EVG 150 mg.

Group Type ACTIVE_COMPARATOR

Raltegravir

Intervention Type DRUG

Raltegravir tablet administered orally twice daily according to prescribing information

EVG placebo

Intervention Type DRUG

Placebo to match elvitegravir administered orally once daily

Background regimen

Intervention Type DRUG

Interventions

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Elvitegravir

Elvitegravir (EVG) tablet administered orally once daily with food

Intervention Type DRUG

Raltegravir

Raltegravir tablet administered orally twice daily according to prescribing information

Intervention Type DRUG

EVG placebo

Placebo to match elvitegravir administered orally once daily

Intervention Type DRUG

RAL placebo

RAL placebo administered orally twice daily.

Intervention Type DRUG

Background regimen

Intervention Type DRUG

Other Intervention Names

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Vitekta® GS-9137 Isentress®

Eligibility Criteria

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Inclusion Criteria

* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
* Documented resistance or at least six months experience prior to screening with two or more different classes of antiretroviral agents
* Stable antiretroviral regimen for at least 30 days prior to screening: however, participants may discontinue the antiretroviral regimen after screening and remain off therapy until baseline at the discretion of the investigator
* Eligible to receive one of the fully-active ritonavir-boosted-PIs, and an allowed second agent
* Normal ECG
* Adequate renal function (estimated glomerular filtration rate according to the Cockcroft-Gault formula ≥ 60 mL/min)
* Hepatic transaminases ≤ 5 × upper limit of normal
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
* Serum amylase \< 1.5 × the upper limit of the normal range
* Negative serum pregnancy test (females of childbearing potential only)
* Males and females of childbearing potential must agree to use highly effective contraception methods
* Age ≥ 18 years
* Life expectancy ≥ 1 year
* Ability to understand and sign a written informed consent form

Exclusion Criteria

* New AIDS-defining condition diagnosed within the 30 days prior to screening
* Prior treatment with any HIV-1 integrase inhibitor
* Participants experiencing ascites
* Participants experiencing encephalopathy
* Females who are breastfeeding
* Positive serum pregnancy test at any time during the study (female of childbearing potential)
* Participants receiving ongoing therapy with any disallowed medication
* Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
* Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Participation in any other clinical trial (except for the etravirine or maraviroc expanded access program), without prior approval from sponsor
* Any other clinical condition or prior therapy that would make participants unsuitable for the study
* Known hypersensitivity to study drug, metabolites or formulation excipients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Szwarcberg, MD, MPH

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Southwest Center for HIV/AIDS

Phoenix, Arizona, United States

Site Status

Health for Life Clinic, PLLC

Little Rock, Arkansas, United States

Site Status

Pacific Oaks Medical Group

Beverly Hills, California, United States

Site Status

AIDS Healthcare Foundation-Research Center

Beverly Hills, California, United States

Site Status

Center for Special Immunology

Fountain Valley, California, United States

Site Status

The Living Hope Foundation

Long Beach, California, United States

Site Status

Kaiser Permanente

Los Angeles, California, United States

Site Status

Jeffrey Goodman Special Care Clinic

Los Angeles, California, United States

Site Status

University of Southern California, AIDS Clinical Trials Unit

Los Angeles, California, United States

Site Status

Peter J. Ruane, MD, Inc.

Los Angeles, California, United States

Site Status

Tony Mills, MD Internal Medicine

Los Angeles, California, United States

Site Status

Orange Coast Medical Group

Newport Beach, California, United States

Site Status

Alameda County Medical Center

Oakland, California, United States

Site Status

East Bay AIDS Center

Oakland, California, United States

Site Status

Kaiser Permanente

Sacramento, California, United States

Site Status

David J. Shamblaw, MD Inc.

San Diego, California, United States

Site Status

Metropolis Medical

San Francisco, California, United States

Site Status

San Francisco VA Medical Center/UCSF

San Francisco, California, United States

Site Status

Connecticut Health Care Group

Glastonbury, Connecticut, United States

Site Status

Circle Medical LLC

Norwalk, Connecticut, United States

Site Status

The Stamford Hospital - Stamford ID

Stamford, Connecticut, United States

Site Status

Whitman-Walker Clinic

Washington D.C., District of Columbia, United States

Site Status

The George Washington University Medical Center

Washington D.C., District of Columbia, United States

Site Status