HIV Infections Clinical Trial
Official title:
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
Verified date | January 2015 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Central Texas Clinical Research | Austin | Texas |
United States | Community Research Initiative of New England | Boston | Massachusetts |
United States | Gordon E. Crofoot, MD, PA | Houston | Texas |
United States | Anthony Mills MD, Inc | Los Angeles | California |
United States | Kaiser Permanente Los Angeles | Los Angeles | California |
United States | Peter J. Ruane, MD, Inc. | Los Angeles | California |
United States | Orlando Immunology Center | Orlando | Florida |
United States | Capital Medical Associates, PC | Washington | District of Columbia |
United States | Dupont Circle Physician's Group | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 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. | Week 12 | No |
Secondary | Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities | 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. | Up to 48 weeks plus 30 days | No |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 | 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 | No |
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