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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00707733 |
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily ritonavir-boosted elvitegravir or twice-daily raltegravir added to a background regimen in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents.
Condition | Intervention | Phase |
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HIV Infection |
Drug: Elvitegravir Drug: Raltegravir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults |
Estimated Enrollment: | 700 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ritonavir-boosted elvitegravir 150 mg QD (ritonavir-boosted elvitegravir 85 mg QD for subjects taking atazanavir/r or lopinavir/r as part of their BR) + BR (N = 350)
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Drug: Elvitegravir
Elvitegravir 85 mg, 150 mg or matching placebo administered orally QD (with ritonavir-boosted PI) to be taken with food
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2: Active Comparator
Raltegravir 400 mg BID + BR (N = 350)
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Drug: Raltegravir
Raltegravir 400 mg tablets or matching placebo administered orally BID and to be taken according to the prescribing information.
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This is a double-blind, double-dummy, multicenter, randomized, active-controlled study to assess the safety and efficacy of a regimen containing ritonavir-boosted elvitegravir versus raltegravir, each administered with a background regimen (BR) containing a fully-active ritonavir-boosted protease inhibitor (PI) and a second single agent in HIV-1 infected, antiretroviral treatment-experienced adults. Subjects will be randomized in a 1:1 ratio to one of the following two treatment arms:
Due to known pharmacokinetic interactions, subjects who are taking atazanavir/r (ATV/r) or lopinavir/r (LPV/r) as part of their BR will receive elvitegravir 85 mg if randomized to Treatment Arm 1.
The BR shall be constructed by the investigator based on viral resistance testing and shall be composed of a fully-active ritonavir-boosted PI and a second single agent.
The fully-active PI is defined by phenotypic resistance analysis. For phenotypic susceptibility, fully active is defined as being below the lower clinical or biological cutoff. The following ritonavir-boosted PIs are allowed to be prescribed by the investigator as part of the BR: atazanavir/r, darunavir/r, fosamprenavir/r, lopinavir/r, or tipranavir/r. Subjects must 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 elvitegravir. No other marketed PIs will be allowed as part of the BR due to unknown pharmacokinetic interactions.
The second single agent may or may not be fully-active and can be one nucleoside or nucleotide reverse transcriptase inhibitor (NRTI), etravirine, maraviroc, or T-20. However, the second single agent must not include an integrase inhibitor; the non-nucleoside reverse transcriptase inhibitors (NNRTI) efavirenz, nevirapine, or delavirdine (due to unknown pharmacokinetic interactions); or fixed-dose combination antiretroviral therapies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew Plummer | 650-522-6173 | Andrew.Plummer@gilead.com |
Study Director: | Steven Chuck, MD | Gilead Sciences |
Responsible Party: | Gilead Sciences, Inc. ( Steven Chuck, MD, Senior Director, Clinical Research ) |
Study ID Numbers: | GS-US-183-0144 |
Study First Received: | June 27, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00707733 |
Health Authority: | United States: Food and Drug Administration |
HIV HIV 1 Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |