Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL)
|First Received Date ICMJE||June 27, 2008|
|Last Updated Date||June 6, 2011|
|Start Date ICMJE||June 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00707733 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To evaluate the efficacy, safety and tolerability of the two treatment arms through 48 weeks of treatment. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL)|
|Official Title ICMJE||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|
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.
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.
Two identical Phase 3 studies of elvitegravir tablets boosted with ritonavir are currently ongoing in treatment-experienced adults with HIV-1 infection. Initiated in July 2008, Study GS-US-183-0144 (planned N=700) is being conducted in the US and Puerto Rico and Study GS-US-183-0145 (planned N=700) is being conducted in Europe, Australia, Mexico and Canada. Given the declining numbers of patients with unsuppressed viremia, Gilead is combining the two ongoing studies into a single, global Phase 3 study (GS-US-183-0145) to enroll a total of 700 subjects. The protocol amendment enables the transfer of subjects from Study GS-US-183-0144 into study GS-US-183-0145.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Condition ICMJE||HIV Infection|
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Enrollment ICMJE||700|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00707733|
|Other Study ID Numbers ICMJE||GS-US-183-0144|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Steven Chuck, MD, Senior Director, Clinical Research, Gilead Sciences, Inc.|
|Study Sponsor ICMJE||Gilead Sciences|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Gilead Sciences|
|Verification Date||June 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP