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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Keywords: HIV-1
HIV
Treatment Experienced
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
timeFrame: Up to 48 weeks plus 30 days
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48
timeFrame: Weeks 24 and 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD, Inc
state: California
city: Washington
country: United States
facility: Dupont Circle Physician's Group
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates, PC
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Houston
country: United States
facility: Gordon E. Crofoot, MD, PA
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Huyen Cao, MD
role: STUDY_DIRECTOR
References: