Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Condition: HIV
Intervention: TMC125, Darunavir; Ritonavir
Intervention description: TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Immunodeficiency Virus, Human; PREZISTA; darunavir; TMC114; TMC125; Protease Inhibitor; Non-Nucleoside Reverse Transcriptase Inhibitor; enfuvirtide; Treatment Experienced

Summary:

      The purpose of this study is to examine the safety, tolerability, and effectiveness of
      darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside
      Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by
      darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate
      enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are
      to remain unchanged.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 positive

          -  History of drug resistance or antiretroviral failure while receiving each of three
             drug classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside
             Reverse Transcriptase Inhibitors (NNRTIs) and (protease inhibitors) PIs

          -  On a PI containing regimen with enfuvirtide with HIV viral load (VL) < 400 copies/mL
             for 6 months or longer

          -  Continuously using the same PI regimen for 4 months prior to Screening

          -  Decline to continue enfuvirtide or their physician recommends discontinuation due to
             injection site reactions that persist despite optimal technique and training with
             available methods of administration or loss of sites for injection due to tissue
             nodules and hardening.

        Exclusion Criteria:

          -  No use of any drug contraindicated in the current US package insert for PREZISTA
             (darunavir) or in the investigators brochure for TMC125

          -  No prior or current therapy with PREZISTA (darunavir) or TMC125

          -  No prior genotypic results demonstrating 3 or more darunavir resistance-associated
             mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V,
             I50V, I54L, I54M, G73S, L76V, I84V or L89V). Patients with > 3 darunavir
             resistance-associated mutations with available darunavir phenotypes, may be enrolled
             if the resistance phenotype demonstrates: Fold Change (FC) <10 to darunavir by
             PhenoSense GT (Monogram Biosciences) or FC <10 to darunavir by Antivirogram (Virco,
             BVBA) or FC <3.4 to darunavir by vircoTYPE (Virco BVBA)

          -  AST or ALT >5 times ULN

          -  Calculated CrCl < 30 ml/min.