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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02345252
First Posted: January 26, 2015
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will evaluate the safety and efficacy of emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) versus continuing emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) FDC in HIV-1 infected adults who are virologically suppressed on a stable regimen of FTC/RPV/TDF for ≥ 6 consecutive months prior to screening.

Condition Intervention Phase
HIV-1 Infection Drug: FTC/RPV/TAF Drug: FTC/RPV/TDF Placebo Drug: FTC/RPV/TDF Drug: FTC/RPV/TAF Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion 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 ]

Secondary Outcome Measures:
  • Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 48 and 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Weeks 48 and 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 Weeks 48 and 96 [ Time Frame: Baseline; Week 48; Week 96 ]
  • Percent Change From Baseline in hip and spine Bone Mineral Density (BMD) at Weeks 48 and 96 [ Time Frame: Baseline; Week 48; Week 96 ]

Enrollment: 632
Actual Study Start Date: January 26, 2015
Estimated Study Completion Date: June 2018
Primary Completion Date: June 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTC/RPV/TAF
FTC/RPV/TAF FDC plus FTC/RPV/TDF placebo for 96 weeks. After Week 96, participants will be given option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks.
Drug: FTC/RPV/TAF
FTC/RPV/TAF (200/25/25 mg) FDC tablets administered orally once daily
Other Name: Odefsey®
Drug: FTC/RPV/TDF Placebo
FTC/RPV/TDF placebo tablets administered orally once daily
Active Comparator: FTC/RPV/TDF
FTC/RPV/TDF FDC plus FTC/RPV/TAF placebo for 96 weeks. After Week 96, participants will be given option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks.
Drug: FTC/RPV/TDF
FTC/RPV/TDF (200/25/300 mg) FDC tablets administered orally once daily
Other Names:
  • Complera®
  • Eviplera®
Drug: FTC/RPV/TAF Placebo
FTC/RPV/TAF placebo tablets administered orally once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (≤ 26μmol/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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345252


  Show 117 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02345252     History of Changes
Other Study ID Numbers: GS-US-366-1216
2014-004545-27 ( EudraCT Number )
First Submitted: January 19, 2015
First Posted: January 26, 2015
Last Update Posted: November 9, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
HIV

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Rilpivirine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents