Atazanavir/Ritonavir (ATV/RTV) Once a Day (QD) + Raltegravir (RAL) Twice a Day (BID) Stable Switch Study (HARNESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01332227
First received: April 7, 2011
Last updated: March 10, 2014
Last verified: March 2014

April 7, 2011
March 10, 2014
October 2011
September 2013   (final data collection date for primary outcome measure)
Proportion of subjects with HIV-1 Ribonucleic acid (RNA) < 40 c/mL through week 24 as measured by quantitative HIV RNA Reverse Transcriptase-Polymerase chain reaction (RT-PCR). [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01332227 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with HIV-1 RNA < 40 c/mL. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Safety as measured by the frequency of Serious Adverse Events (SAEs), the frequency of Adverse Events(AEs), frequency of AEs leading to discontinuation, the frequency of lab abnormalities and by changes from baseline in fasting lipids. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Safety as measured by the frequency of SAEs, the frequency of AEs, frequency of AEs leading to discontinuation, the frequency of lab abnormalities and by changes from baseline in fasting lipids. [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Incidence of resistance and characterization of this resistance following a virological rebound [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Incidence of resistance and characterization of this resistance following a virological rebound [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Atazanavir/Ritonavir (ATV/RTV) Once a Day (QD) + Raltegravir (RAL) Twice a Day (BID) Stable Switch Study
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

The purpose of this study is to evaluate if HIV-1 infected subjects who are virologically suppressed on a regimen which consists of 2 Nucleoside reverse transcriptase inhibitor's (NRTI) plus any 3rd agent but who are experiencing safety and/or tolerability issues to this regimen will continue to maintain virologic suppression following a switch to a regimen consisting of heat-stable Ritonavir boosted Atazanavir (300/100mg) once daily plus Raltegravir (400mg) twice daily.

Allocation: Randomized Non-Stratified

Intervention Model: Parallel Versus Comparator(s)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV, Combination Therapy
  • Drug: Atazanavir
    Capsules, Oral, 300mg, Once daily, 48 weeks
    Other Name: Reyataz
  • Drug: Ritonavir (heat-stable)
    Tablets, Oral, 100 mg, Once daily, 48 weeks
    Other Name: Norvir
  • Drug: Raltegravir
    Tablets, Oral, 400 mg, Twice daily, 48 weeks
    Other Name: Isentress
  • Drug: Tenofovir/Emtricitabine
    Tablets, Oral, 300/200 mg, Once daily, 48 weeks
    Other Name: Truvada
  • Experimental: Arm 1
    Atazanavir + Ritonavir (heat-stable) + Raltegravir
    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir (heat-stable)
    • Drug: Raltegravir
  • Arm 2

    Reference

    Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine

    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir (heat-stable)
    • Drug: Tenofovir/Emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
February 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are on a treatment regimen consisting of 2 NRTI + any 3rd agent for at least 3 months immediately prior to screening
  • Subjects who are virologically suppressed (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
  • Subjects who are virologically suppressed (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® PCR assay) during screening period
  • Subjects who are experiencing treatment related safety and/or tolerability issues to a regimen consisting of 2 NRTI + any 3rd. agent

Exclusion Criteria:

  • History of HAART treatment regimen switch due to virological failure
  • History of genotypic resistance to any component of the study regimen [Atazanavir (ATV), Raltegravir (RAL), Tenofovir/Emtricitabine (TDF/FTC)]
  • History of previous exposure to Atazanavir/Ritonavir (ATV/RTV) or RAL prior to entering the study
  • Subjects experiencing safety and/or tolerability issues to TDF/FTC or RTV
  • Subjects who have switched any component of their Human Immunodeficiency Virus (HIV) Antiretroviral (ARV) medication in the last 3 months immediately prior to screening or during the screening period
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Poland,   Spain,   United Kingdom
 
NCT01332227
AI424-402, 2009-017032-41
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Mayers Squibb Bristol-Mayers Squibb
Bristol-Myers Squibb
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP