Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
NCT ID: NCT00445146
Last Updated: 2016-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2007-02-28
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EVG+RTV
EVG 85 mg or 150 mg + RTV + ARV regimen
Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.
Some participants may receive EVG 300 mg during the course of protocol amendment 2.
EVG
Elvitegravir (EVG) tablet administered orally once daily with food
RTV
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
ARV regimen
The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
Interventions
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EVG
Elvitegravir (EVG) tablet administered orally once daily with food
RTV
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
ARV regimen
The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females of childbearing potential must agree to utilize effective contraception methods.
* Ability to understand and sign a written informed consent form.
Exclusion Criteria
* Participation in any other clinical trial without prior approval from the Sponsor.
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
* Subjects receiving ongoing therapy with contraindicated drugs.
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Rhee, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Pheonix, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Fort Lauderdale, Florida, United States
Manors, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
North Palm Beach, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
West Springfield, Massachusetts, United States
Saint Louis, Michigan, United States
Henderson, Nevada, United States
Hillsborough, New Jersey, United States
Santa Fe, New Mexico, United States
Albany, New York, United States
Manhasset, New York, United States
New York, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Annandale, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Santurce, , Puerto Rico
Countries
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Other Identifiers
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GS-US-183-0130
Identifier Type: -
Identifier Source: org_study_id
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