Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02345252
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : December 8, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 19, 2015
First Posted Date  ICMJE January 26, 2015
Results First Submitted Date  ICMJE September 20, 2017
Results First Posted Date  ICMJE December 8, 2017
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE January 26, 2015
Actual Primary Completion Date June 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2015)
Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot algorithm [ Time Frame: Week 48 ]
Change History Complete list of historical versions of study NCT02345252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  • Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ]
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96 [ Time Frame: Baseline and Week 96 ]
    Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]
    Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96 [ Time Frame: Baseline and Week 96 ]
    Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2015)
  • Change from baseline in CD4+ cell count [ Time Frame: Baseline; Week 48 ]
  • Percent change from baseline in hip and spine bone mineral density (BMD) [ Time Frame: Baseline; Week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Official Title  ICMJE A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Brief Summary The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: FTC/RPV/TAF
    200/25/25 mg FDC tablets administered orally once daily
    Other Name: Odefsey®
  • Drug: FTC/RPV/TDF Placebo
    Tablets administered orally once daily
  • Drug: FTC/RPV/TDF
    200/25/300 mg FDC tablets administered orally once daily
    Other Names:
    • Complera®
    • Eviplera®
  • Drug: FTC/RPV/TAF Placebo
    Tablets administered orally once daily
Study Arms  ICMJE
  • Experimental: FTC/RPV/TAF
    FTC/RPV/TAF FDC plus FTC/RPV/TDF placebo for at least 96 weeks. After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF FDC for oral once-daily use, and attend visits every 12 weeks until FTC/RPV/TAF FDC becomes commercially available, or until Gilead Sciences elects to discontinue the study, whichever occurs first.
    Interventions:
    • Drug: FTC/RPV/TAF
    • Drug: FTC/RPV/TDF Placebo
  • Active Comparator: FTC/RPV/TDF
    FTC/RPV/TDF FDC plus FTC/RPV/TAF placebo for at least 96 weeks. After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF FDC for oral once-daily use, and attend visits every 12 weeks until FTC/RPV/TAF FDC becomes commercially available, or until Gilead Sciences elects to discontinue the study, whichever occurs first.
    Interventions:
    • Drug: FTC/RPV/TDF
    • Drug: FTC/RPV/TAF Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2015)
632
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2015)
550
Actual Study Completion Date  ICMJE January 9, 2019
Actual Primary Completion Date June 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Currently receiving FTC/RPV/TDF FDC for ≥ 6 consecutive months preceding the screening visit
  • Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed
  • Have no documented resistance to any of the study agents at any time in the past
  • HIV-1 RNA < 50 copies/mL at the screening visit
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL (≤ 26 μmol/L), or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3 (1.00 GI/L); platelets ≥ 50,000/mm^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L))
  • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
  • Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (1.17 mL/sec) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)
  • Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
  • Individuals receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the individual agents Prescribing Information); or individuals with any known allergies to the excipients of FTC/RPV/TAF

Note: Other Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Puerto Rico,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02345252
Other Study ID Numbers  ICMJE GS-US-366-1216
2014-004545-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP