- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01533259
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
January 16, 2015 updated by: Gilead Sciences
A Phase 3B Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single-Tablet Regimen (STR) in Virologically Suppressed, HIV-1 Infected Patients
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults.
This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles
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Los Angeles, California, United States, 90036
- Peter J. Ruane, MD, Inc.
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Los Angeles, California, United States, 90069
- Anthony Mills MD, Inc
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District of Columbia
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Washington, District of Columbia, United States, 20009
- Dupont Circle Physician's Group
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Washington, District of Columbia, United States, 20036
- Capital Medical Associates, PC
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Florida
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Orlando, Florida, United States, 32803
- Orlando Immunology Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Community Research Initiative of New England
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Texas
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Austin, Texas, United States, 78705
- Central Texas Clinical Research
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Houston, Texas, United States, 77098
- Gordon E. Crofoot, MD, PA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to understand and sign a written informed consent form
Virologically stable on the current first antiretroviral regimen consisting only of raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and
- have documented undetectable plasma HIV-1 RNA levels ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and
- have never experienced two consecutive HIV-1 RNA above detectable levels after first achieving a confirmed HIV-1 RNA level below detectable levels on the first regimen
- HIV-1 RNA < 50 copies/mL at the screening visit
- Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time
- Normal ECG
- Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Estimated glomerular filtration rate ≥ 70 mL/min
- Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner from screening throughout the duration of the study period and for 30 days following the last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or must be non heterosexually active, practice sexual abstinence, or be vasectomized
Exclusion Criteria:
- New AIDS defining condition diagnosed within the 21 days prior to screening
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Individuals with acute or chronic hepatitis B or hepatitis C co-infection
- Individuals experiencing decompensated cirrhosis
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance abuse that would interfere with compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to the baseline visit
- Receiving any investigational drugs
- Participation in any other clinical trial without prior approval from the sponsor
- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
- Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with the dosing requirements
- Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with Stribild; or individuals with known allergies to the excipients of the Stribild single tablet regimen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stribild
Participants will switch to Stribild for 48 weeks.
|
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
Time Frame: Week 12
|
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
Time Frame: Up to 48 weeks plus 30 days
|
This outcome measure assessed the safety and tolerability profile of Stribild.
Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.
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Up to 48 weeks plus 30 days
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48
Time Frame: Weeks 24 and 48
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The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
|
Weeks 24 and 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
February 2, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (Estimate)
February 15, 2012
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- GS-US-236-0123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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