Switching Undetectables to Selzentry

NCT01866267 | Completed Phase 4 DMC

• 1 other identifier: SUDS_GSK117335
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; AIDS

Keywords

Human Immunodeficiency Virus; AIDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Effectiveness of once-daily Selzentry® through Week 48

  At Week 48

• The safety of once-daily Selzentry® through Weeks 24 and 48

  Through Weeks 24 and 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

• Resistance-Associated Mutations or Tropism Changes from Baseline

  at Weeks 24 and 48

Study Arms (1)

Maraviroc

OTHER

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

Interventions

Maraviroc DRUG

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.

Also known as: Selzentry®, Celsentri®

Maraviroc

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Hope Foundation: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

St. Hope Foundation, Inc.

Bellaire, Texas, 77401, United States

Location

Related Links

• Health Psychology Research, LTD - source of HIV treatment regimen satisfaction assessment instrument

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stanley T. Lewis, M.D., MPH

  St. Hope Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

US (1)