A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
Condition: Human Immunodeficiency Virus-type 1 Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Rilpivirine; Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine
Intervention description: Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.; Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.; Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.; Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz; Rilpivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human immunodeficiency virus-type 1 infection; HIV-1; Infectious diseases; Ribonucleic acid; RNA; Tenofovir disoproxil fumarate; Emtricitabine; Rilpivirine; Efavirenz; Edurant; TMC278; R278474; Fixed dose combination

Summary:

      The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to
      standard treatment) in terms of the percentage of patients who have plasma human
      immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per
      mL after 48 weeks of randomized treatment with tenofovir disoproxil
      fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).
    

Eligibility criteria:

        Inclusion Criteria:

        Documented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been
        receiving first line highly active antiretroviral therapy (HAART) for at least 1 year
        before the screening visit Patients who have been taking the same ARV combination for at
        least 8 weeks before the screening visit and are expected to continue on this regimen
        throughout the screening period.

        Patients who prefer to change the current HAART regimen for reasons of simplification
        and/or toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI) Plasma
        HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the
        screening visit Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

        History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than
        or equal to 400 copies per mL) while on previous or current ART History of immunologic
        failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART
        level) History of any primary N[t]RTI or NNRTI mutations Has a previously documented HIV-2
        infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed
        with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection
        Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to
        drug, including alcohol or recreational drugs