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

Phase 3

Completed

Conditions: Acquired Immunodeficiency Syndrome
HIV Infections

Interventions: Drug: Stribild

Registration Number: NCT01533259

Lead Sponsor: Gilead Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stribild	Stribild	Participants will switch to Stribild for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities	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.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48	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.

Trial Locations

Locations (9): Kaiser Permanente Los Angeles
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Los Angeles, California, United States
Anthony Mills MD, Inc
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Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
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Los Angeles, California, United States
Central Texas Clinical Research
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Austin, Texas, United States
Gordon E. Crofoot, MD, PA
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Houston, Texas, United States
Community Research Initiative of New England
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Boston, Massachusetts, United States
Orlando Immunology Center
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Orlando, Florida, United States
Capital Medical Associates, PC
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Washington, District of Columbia, United States
Dupont Circle Physician's Group
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Washington, District of Columbia, United States