Switching Undetectables to Selzentry (SUDS)

A Study in HIV+ Patients With CCR5-tropic Virus and Undetectable Viral Load on a First, Non-Selzentry®-Containing Regimen, Switching Them to Once-daily Selzentry® (600mg qd) Plus the Same 2 NRTIs Previously Administered

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus; AIDS
• Intervention / Treatment: Drug: Maraviroc

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • St. Hope Foundation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Are capable of understanding and have signed an informed consent
• Have documented HIV-1 infection by confirmatory laboratory
• Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
• Are able and willing to comply with all protocol requirements and procedures
• Have HIV-1 RNA <100 copies/mL and documented CCR5 tropic virus
• Are receiving their first highly active antiretroviral regimen for at least 12 weeks before screening and are willing to continue that regimen until the baseline visit (previous regimen modifications for reasons other than virologic failure are acceptable if any previously achieved virologic suppression has been maintained)
• Antiretroviral regimen is composed of one NNRTI, one PI (including boosted PIs), or one integrase inhibitor AND two (2) NRTIs

Exclusion Criteria:

• Any history of virologic failure or resistance associated mutations on prior resistance testing
• Any history of dual/mixed- or CXCR4-tropic HIV-1
• Any history of an active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
• Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
• Any significant acute illness within 1 week before the initial administration of study drug
• Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e. secondary prophylaxis for opportunistic infections) will be eligible for the study
• HCV infection requiring treatment during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Maraviroc; 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.

Drug: Maraviroc; 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 Names: Selzentry®; Celsentri®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Once-Daily Selzentry® through Week 24	Percentage of HIV positive patients with Undetectable Viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of once-daily Selzentry® through Week 48	The percentage of HIV positive patients with undetectable viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI at Week 48	At Week 48
The safety of once-daily Selzentry® through Weeks 24 and 48	The safety of once-daily Selzentry® plus 2 NRTI measured by the frequency and severity of drug-related adverse events (including laboratory abnormalities) through Weeks 24 and 48 of the study.	Through Weeks 24 and 48
The change from baseline in CD4+ T-cell counts	A change from the baseline measurement in CD4+ T-cell counts at Weeks 24 and 48 of the study.	at Weeks 24 and 48
The change from baseline in inflammatory markers (C-reactive protein)	The change from the baseline measurement in inflammatory markers (C-reactive protein) at Weeks 24 and 48 of the study.	at Weeks 24 and 48
Resistance-Associated Mutations or Tropism Changes from Baseline	Assessment of any resistance-associated mutations or changes in viral tropism compared to baseline, if any, that emerge upon the occurrence of virologic failure.	at Weeks 24 and 48
Tolerability of Once-Daily Selzentry®	The tolerability of once-daily Selzentry® plus 2 NRTI as measured by patient responses to the treatment regimen satisfaction questionnaire, assessed at Weeks 24 and 48 of the study.	Through Weeks 24 and 48

Collaborators and Investigators

• Sponsor: St. Hope Foundation
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Stanley T. Lewis, M.D., MPH, St. Hope Foundation, Inc.

Publications and helpful links

Helpful Links

• Information on "Trofile" viral tropism testing
• Health Psychology Research, LTD - source of HIV treatment regimen satisfaction assessment instrument

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: AIDS; Human Immunodeficiency Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; CCR5 Receptor Antagonists; Maraviroc
• Other Study ID Numbers: SUDS_GSK117335