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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533259
• Other study ID #: GS-US-236-0123
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2012
• Last updated: January 16, 2015
• Start date: January 2012
• Est. completion date: July 2013

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Stribild
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

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