TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
Condition: HIV Infections; HIV-1
MeSH terms: HIV Infections
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 background regimen containing 2 nucleoside/nucleotide reverse
      transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) 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 and 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 (like tossing a coin) to TMC278 or to efavirenz in combination with two
      other anti-HIV drugs of the class nucleoside/nucleotide reverse transcriptase inhibitors. 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 daily; plus efavirenz (EFV)
      placebo; plus 2 nucleoside/nucleotide reverse transcriptase inhibitors; Control Group: One
      tablet of Placebo daily that looks just like TMC278 plus EFV 600 mg daily plus 2
      nucleoside/nucleotide reverse transcriptase inhibitors for 104 weeks.
    

Intervention name(s): TMC278; efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet once daily for 96 weeks; 600 mg tablet 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: Antiretroviral; HIV-1; AIDS; TMC278-C215; TMC278-TiDP6-C215; Treatment Naive