TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
Condition: HIV Infections; HIV-1; Human Immunodeficiency Virus Type 1
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278
      given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,
      when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir
      disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV
      drugs. The following evaluations will be done: antiviral activity, immunologic changes, and
      viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and
      PK/Pharmacodynamics, medical resource utilization and treatment adherence.
    

Detailed description: 
      Over the past decade, anti-human immunodeficiency virus (HIV) drugs have been introduced
      sequentially for use in the clinic. Currently, patients are routinely being treated with 3 or
      4 drug combinations including nucleoside/tide analogue reverse transcriptase inhibitors
      (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors
      (PIs), and/or fusion inhibitors. New potent antiretroviral (ARV) compounds that work in
      people whose HIV-1 virus is resistant to available drugs are urgently needed. This is a Phase
      III, randomized (study medication is assigned by chance), double-blind (neither the study
      physician nor the patient knows the name of the study assigned medication), double-dummy,
      active-controlled trial to compare the effectiveness, safety, and ability to tolerate TMC278
      versus efavirenz (EFV). The study will last for 104 weeks which includes a screening period
      of 4 weeks, a 96-week treatment period, followed by a 4 week follow-up period. Patients will
      be randomly assigned to TMC278 or to efavirenz, either of these treatments will be in
      combination with two other anti-HIV drugs (2 NRTIs: emtricitabine (FTC) + tenofovir (TDF)).
      TDF/FTC will be administered as a fixed dose combination if available. The hypothesis to be
      provided in this study is that the investigational drug TMC278 will perform just like
      efavirenz (EFV) in terms of antiviral effectiveness (i.e., suppressing of the plasma viral
      load to a level < 50 HIV-1 RNA (ribonucleic acid) copies/mL) in ARV-naïve HIV-infected
      patients. During the trial, patients' health will be monitored by physical examination,
      interview to assess health and well being, and laboratory testing on blood and urine samples.
      Experimental Group: One tablet of TMC278 25 mg once daily plus one tablet of placebo once
      daily that looks just like efavirenz (EFV) plus tenofovir/emtricitabine; Control Group: One
      tablet of Placebo once daily that looks just like TMC278 plus EFV 600 mg once daily plus
      tenofovir/emtricitabine.
    

Intervention name(s): TMC278; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet once daily for 96 weeks; 600mg once daily for 96 weeks
Intervention MeSH terms: Efavirenz; Rilpivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMC278-C209; Antiretroviral; Non-nucleoside reverse transcriptase inhibitor; HIV-1; AIDS; TMC278-TiDP6-C209; Treatment Naive