A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Etravirine (ETR); Nucleotide reverse transcriptase inhibitors (NRTIs); Protease inhibitors (PIs); Enfuvirtide (ENF)
Intervention description: Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available.; Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).; Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).; Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
Intervention MeSH terms: Reverse Transcriptase Inhibitors; Etravirine; Enfuvirtide; HIV Protease Inhibitors; Protease Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus Type 1; HIV-1 infection; TMC125; Etravirine; Enfuvirtide; Antiretroviral therapy

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of etravirine,
      administered as part of an individually optimized antiretroviral therapy (ART), in human
      immunodeficiency virus Type 1 (HIV-1) infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who were previously randomized to an etravirine (ETR) treatment arm and
             have completed at least 48 weeks of treatment with ETR

          -  Participants who will be able to comply with the protocol requirements

          -  Participants general medical condition should not interfere with the assessments and
             the completion of the study

        Exclusion Criteria:

          -  Use of disallowed concomitant therapy unless a prior exemption had been granted

          -  Participant with any treatment-emergent condition or exacerbation of underlying
             condition during original Phase II study

          -  Agrees to protocol-defined use of effective contraception

          -  Participant with a grade 3 elevation of amylase and/or lipase except for isolated
             grade 3 increases of amylase with lipase in normal range and no history of
             pancreatitis

          -  Participant with any grade 4 toxicity according to the Division of Acquired
             Immunodeficiency Syndrome (DAIDS) grading table; with the exception of grade 4
             elevations of triglycerides or glucose asymptomatic or under non-fasting conditions;
             grade 4 elevation of glucose in participants with pre-existing diabetes

          -  Participants with clinical or laboratory evidence of significantly decreased hepatic
             function or decompensation, irrespective of liver enzyme levels (International
             Normalized Ratio [INR] more than 1.5 or albumin less than 30g/l or bilirubin more than
             2.5 x upper limit of normal)