Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
Condition: HIV-1 Infection
Intervention: FTC/RPV/TDF
Intervention description: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Intervention MeSH terms: Emtricitabine, Rilpivirine, Tenofovir Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment Experienced

Summary:

      The purpose of this Phase 2b study was to evaluate the efficacy and safety of the
      emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching
      from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at
      Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months
      prior to study start, were experiencing safety or tolerability concerns (in particular,
      EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and sign a written informed consent form

          -  Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit

          -  Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for
             ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening
             visit

          -  On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured
             at two consecutive time points after first achieving HIV RNA < 50 copies/mL

          -  Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the
             study agents

          -  Normal ECG

          -  Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

          -  Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥
             50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

          -  Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serum
             lipase ≤ 5 x ULN)

          -  Adequate renal function (estimated glomerular filtration rate ≥ 50 mL/min according to
             the Cockcroft-Gault formula)

          -  Males and Females of childbearing potential must have agreed to utilize highly
             effective contraception methods (two separate forms of contraception, one of which
             must be an effective barrier method, or be nonheterosexually active, practice sexual
             abstinence, or have a vasectomized partner) from screening throughout the duration of
             the study period and for 60 days following the last dose of study drug.

          -  Age ≥ 18 years

          -  Life expectancy ≥ 1 year

        Exclusion Criteria:

          -  A new AIDS-defining condition diagnosed within 21 days prior to screening

          -  Females who were breastfeeding

          -  Positive serum pregnancy test (female of childbearing potential)

          -  Proven or suspected acute hepatitis in the 21 days prior to study entry

          -  Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive
             treatment for Hepatitis C during the course of the study, or with a history of liver
             disease

          -  Was experiencing decompensated cirrhosis

          -  Implanted defibrillator or pacemaker

          -  Current alcohol or substance abuse judged by the Investigator to potentially interfere
             with subject compliance

          -  History of malignancy within the past 5 years or ongoing malignancy other than
             cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
             squamous carcinoma

          -  Active, serious infections requiring parenteral antibiotic or antifungal therapy
             within 21 days prior to Baseline

          -  All investigational drugs

          -  Ongoing therapy or anticipated need to initiate drugs or herbal/natural supplements
             during the study that were contraindicated or not recommended for use as indicated in
             the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with
             known allergies to the excipients of the FTC/RPV/TDF STR

          -  Participation in any other clinical trial without prior approval from the sponsor was
             prohibited while participating in this trial

          -  Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months
             of study screening, or expected to receive these agents or systemic steroids during
             the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based
             therapies)

          -  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
             the dosing requirements