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)
Condition: HIV-1 Infection
Intervention: FTC/RPV/TAF; FTC/RPV/TDF Placebo; FTC/RPV/TDF; FTC/RPV/TAF Placebo
Intervention description: 200/25/25 mg FDC tablets administered orally once daily; Tablets administered orally once daily; 200/25/300 mg FDC tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Emtricitabine, Rilpivirine, Tenofovir Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

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.
    

Eligibility 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 (≤ 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 individual's 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 individual 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 disallowed medications listed in
             the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals
             with any known allergies to the excipients of FTC/RPV/TAF

        Note: Other Inclusion/Exclusion criteria may apply.