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Switching Undetectables to Selzentry (SUDS)

Primary Purpose

Human Immunodeficiency Virus, AIDS

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
St. Hope Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, AIDS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Hope Foundation, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Maraviroc

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
February 12, 2013
Last Updated
November 18, 2014
Sponsor
St. Hope Foundation
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01866267
Brief Title
Switching Undetectables to Selzentry
Acronym
SUDS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Hope Foundation
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, AIDS
Keywords
Human Immunodeficiency Virus, AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry®, Celsentri®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of Once-Daily Selzentry® through Week 24
Description
Percentage of HIV positive patients with Undetectable Viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Effectiveness of once-daily Selzentry® through Week 48
Description
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
Time Frame
At Week 48
Title
The safety of once-daily Selzentry® through Weeks 24 and 48
Description
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.
Time Frame
Through Weeks 24 and 48
Title
The change from baseline in CD4+ T-cell counts
Description
A change from the baseline measurement in CD4+ T-cell counts at Weeks 24 and 48 of the study.
Time Frame
at Weeks 24 and 48
Title
The change from baseline in inflammatory markers (C-reactive protein)
Description
The change from the baseline measurement in inflammatory markers (C-reactive protein) at Weeks 24 and 48 of the study.
Time Frame
at Weeks 24 and 48
Title
Resistance-Associated Mutations or Tropism Changes from Baseline
Description
Assessment of any resistance-associated mutations or changes in viral tropism compared to baseline, if any, that emerge upon the occurrence of virologic failure.
Time Frame
at Weeks 24 and 48
Title
Tolerability of Once-Daily Selzentry®
Description
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.
Time Frame
Through Weeks 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley T. Lewis, M.D., MPH
Organizational Affiliation
St. Hope Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Hope Foundation, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.monogramvirology.com/hiv-tests/resistance-testing/tropism/trofile-dna/
Description
Information on "Trofile" viral tropism testing
URL
http://www.healthpsychologyresearch.com
Description
Health Psychology Research, LTD - source of HIV treatment regimen satisfaction assessment instrument

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Switching Undetectables to Selzentry

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