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Switching Undetectables to Selzentry (SUDS)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Hope Foundation
ClinicalTrials.gov Identifier:
NCT01866267
First received: February 12, 2013
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus
AIDS
Drug: Maraviroc
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by St. Hope Foundation:

Primary Outcome Measures:
  • Effectiveness of Once-Daily Selzentry® through Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    Percentage of HIV positive patients with Undetectable Viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI


Secondary Outcome Measures:
  • Effectiveness of once-daily Selzentry® through Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    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

  • The safety of once-daily Selzentry® through Weeks 24 and 48 [ Time Frame: Through Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
    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.

  • The change from baseline in CD4+ T-cell counts [ Time Frame: at Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
    A change from the baseline measurement in CD4+ T-cell counts at Weeks 24 and 48 of the study.

  • The change from baseline in inflammatory markers (C-reactive protein) [ Time Frame: at Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
    The change from the baseline measurement in inflammatory markers (C-reactive protein) at Weeks 24 and 48 of the study.

  • Resistance-Associated Mutations or Tropism Changes from Baseline [ Time Frame: at Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
    Assessment of any resistance-associated mutations or changes in viral tropism compared to baseline, if any, that emerge upon the occurrence of virologic failure.

  • Tolerability of Once-Daily Selzentry® [ Time Frame: Through Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 31
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866267

Locations
United States, Texas
St. Hope Foundation, Inc.
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
St. Hope Foundation
GlaxoSmithKline
Investigators
Principal Investigator: Stanley T. Lewis, M.D., MPH St. Hope Foundation, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: St. Hope Foundation
ClinicalTrials.gov Identifier: NCT01866267     History of Changes
Other Study ID Numbers: SUDS_GSK117335
Study First Received: February 12, 2013
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Hope Foundation:
Human Immunodeficiency Virus
AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Integrase Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014