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
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: Stribild
Intervention description: 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
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment Experienced

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.
    

Eligibility criteria:

        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