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A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01102972
First received: April 8, 2010
Last updated: October 24, 2013
Last verified: September 2013
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: Reyataz + Norvir + Truvada
Drug: Reyataz + Epzicom

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants (PAR) were recruited from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HLA-B*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA <75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Participant Flow:   Overall Study
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
STARTED     199 [1]   97 [1]
Completed Week 24     180     88  
COMPLETED     170 [2]   83 [2]
NOT COMPLETED     29     14  
Adverse Event                 8                 2  
Lack of Efficacy                 2                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 10                 5  
Investigator Discretion                 2                 0  
Withdrawal by Subject                 6                 6  
[1] 297 PAR enrolled. 1 PAR withdrew before taking investigational product and didn’t “start” the study.
[2] These participants completed Study Week 48.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis   [ Time Frame: Week 24 ]

5.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis   [ Time Frame: Week 48 ]

6.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses   [ Time Frame: Week 24 ]

7.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses   [ Time Frame: Week 48 ]

8.  Secondary:   Change From Baseline in HIV-1 RNA at Week 24   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline in HIV-1 RNA at Week 48   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 24   [ Time Frame: Baseline and Week 24 ]

11.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]

12.  Secondary:   Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24   [ Time Frame: Baseline and Week 24 ]

13.  Secondary:   Change From Baseline in Cholesterol/HDL Ratio at Week 24   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48   [ Time Frame: Baseline and Week 48 ]

15.  Secondary:   Change From Baseline in Cholesterol/HDL Ratio at Week 48   [ Time Frame: Baseline and Week 48 ]

16.  Secondary:   Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24   [ Time Frame: From Baseline to Week 24 ]

17.  Secondary:   Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48   [ Time Frame: From Baseline to Week 48 ]

18.  Secondary:   Number of Participants Who Experienced Death and/or Disease Progression   [ Time Frame: From Baseline to Week 48 ]

19.  Secondary:   Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24   [ Time Frame: From Baseline to Week 24 ]

20.  Secondary:   Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48   [ Time Frame: From Baseline to Week 48 ]

21.  Secondary:   Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir   [ Time Frame: From Baseline to Week 24 ]

22.  Secondary:   Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir   [ Time Frame: From Baseline to Week 48 ]

23.  Secondary:   Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group   [ Time Frame: From Baseline to Week 24 ]

24.  Secondary:   Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group   [ Time Frame: From Baseline to Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study consists of a 35-day Screening Period, a 48-week Treatment Period, and a Follow-up Period (contact ~2-4 weeks after the Week 48/Withdrawal Visit). Data from Week 24 (primary endpoint) and Week 48 (final data) are presented in this summary.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


Publications of Results:
D. Wohl, L. Bhatti, C. B. Small, H. Edelstein, H. Zhao, D. A. Margolis, L. L. Ross, M.S. Shaefer. Simplification to Abacavir/Lamivudine (ABC/3TC) + Atazanavir (ATV) from Tenofovir/Emtricitabine (TDF/FTC) + ATV/Ritonavir (RTV, /r) Maintains Viral Suppression and Improves Bone Biomarkers. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 9-12, 2012; San Francisco, CA. Oral presentation H-556c.

Other Publications:
Robertson K, Maruff P, Wohl D, et al. Similar cognition outcomes after 24 weeks for tenofovir/FTC + atazanavir/r (ATV/r)-experienced HIV+ subjects or subjects simplifying to abacavir/3TC+ATV. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01102972     History of Changes
Other Study ID Numbers: 113734
Study First Received: April 8, 2010
Results First Received: November 28, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration