Switching Undetectables to Selzentry
Condition: Human Immunodeficiency Virus; AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30) HIV
      positive patients infected with CCR5 tropic virus that have achieved an undetectable viral
      load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse
      Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase
      Inhibitor (NRTI)] and switch them to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs.
    

Detailed description: 
      The objective of the study is to determine if regimen tolerability/toxicity can be maintained
      or improved while maintaining virologic suppression following a switch to once-daily
      Selzentry®.

      The study duration is 48 weeks. Patients must have an HIV-1 RNA <100 copies/mL for ≥3 months
      on their first HIV treatment regimen. Prior regimen modifications for reasons other than
      virologic failure are acceptable if any previously achieved virologic suppression has been
      maintained. A Trofile® DNA will be used to document exclusive CCR5 tropism. Patients with
      history of dual/mixed or CXCR4-tropic HIV-1 are excluded from participation. Patients with
      prior exposure to Selzentry® are also excluded. Patients that qualify for participation will
      discontinue the PI, NNRTI, or Integrase inhibitor portion of their regimen and begin
      Selzentry® 600mg QD. Patients will continue the two (2) NRTIs from the previous treatment
      regimen.

      The primary endpoints is: the percentage of HIV positive patients with undetectable viral
      load (HIV-1 RNA <100 copies/mL) at Week 24.

      Secondary endpoints are: the safety and tolerability of once-daily Selzentry® through Weeks
      24 and 48(as measured by clinical and laboratory adverse events and regimen satisfaction
      questionnaire), the percentage of HIV positive patients with undetectable viral load (HIV-1
      RNA < 100 copies/mL) at Week 48, the change from baseline in CD4+ T-cell counts at Weeks 24
      and 48, the change from baseline in inflammatory markers (C-reactive protein) at Weeks 24 and
      48, and assessment of resistance-associated mutations or viral tropism changes from baseline,
      if any, emerging at virologic failure.
    

Intervention name(s): Maraviroc
Intervention type(s): Drug
Intervention description(s): HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] are switched to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs previously administered.
Other intervention name(s): Selzentry®; Celsentri®
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus; AIDS