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Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00440947
First received: February 23, 2007
Last updated: March 15, 2012
Last verified: July 2011
Results First Received: May 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Interventions: Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)

  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 at 66 centers in the United States of America and Canada. HIV-RNA, human immunodeficiency virus-ribonucleic acid; ml, milliliters.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a 36-week Non-randomized Induction Phase, followed by an 84-week Randomized Phase. All PAR completing 84 weeks were eligible to enter an optional 60-week extension phase (EP); some PAR chose not to continue in the EP. PAR whose HIV-RNA wasn't <50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
ABC/3TC + ATV: Randomization Phase Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
ABC/3TC + ATV/r: Randomization Phase Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
ABC/3TC + ATV: Extension Phase Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Participant Flow for 3 periods

Period 1:   36-Week Induction Phase
    ABC/3TC + ATV/r: Induction Phase   ABC/3TC + ATV: Randomization Phase   ABC/3TC + ATV/r: Randomization Phase   ABC/3TC + ATV: Extension Phase   ABC/3TC + ATV/r: Extension Phase
STARTED   515   0   0   0   0 
COMPLETED   442 [1]   0   0   0   0 
NOT COMPLETED   73   0   0   0   0 
Adverse Event                16                0                0                0                0 
Insufficient Viral Load Response                11                0                0                0                0 
Protocol-defined Virologic Failure                5                0                0                0                0 
Non-compliance                10                0                0                0                0 
Lost to Follow-up                16                0                0                0                0 
Withdrawal by Subject                7                0                0                0                0 
Kaposi Lesions Requiring Chemotherapy                1                0                0                0                0 
Took Exclusionary Medications                1                0                0                0                0 
Genotype Had Exclusionary Mutations                1                0                0                0                0 
Fleeing Police; Outstanding Warrants                1                0                0                0                0 
Incarceration                3                0                0                0                0 
Pregnancy                1                0                0                0                0 
[1] 23 PAR without confirmed HIV-RNA<50c/mL prior to Wk 36 couldn’t be randomized but weren’t withdrawn.

Period 2:   48-Week Randomization Phase
    ABC/3TC + ATV/r: Induction Phase   ABC/3TC + ATV: Randomization Phase   ABC/3TC + ATV/r: Randomization Phase   ABC/3TC + ATV: Extension Phase   ABC/3TC + ATV/r: Extension Phase
STARTED   0   210   209   0   0 
COMPLETED   0   194   185   0   0 
NOT COMPLETED   0   16   24   0   0 
Adverse Event                0                2                5                0                0 
Protocol-defined Virologic Failure                0                1                1                0                0 
Non-compliance                0                3                4                0                0 
Lost to Follow-up                0                2                8                0                0 
Protocol Violation                0                0                1                0                0 
Withdrawal by Subject                0                2                4                0                0 
Pregnancy                0                0                1                0                0 
Incarceration                0                3                0                0                0 
Trying to Get Pregnant                0                1                0                0                0 
Physician Decision                0                2                0                0                0 

Period 3:   Optional 60-Week Extension Phase
    ABC/3TC + ATV/r: Induction Phase   ABC/3TC + ATV: Randomization Phase   ABC/3TC + ATV/r: Randomization Phase   ABC/3TC + ATV: Extension Phase   ABC/3TC + ATV/r: Extension Phase
STARTED   0   0   0   189   180 
COMPLETED   0   0   0   160   154 
NOT COMPLETED   0   0   0   29   26 
Adverse Event                0                0                0                1                3 
Insufficient Viral Load Response                0                0                0                1                1 
Protocol-defined Virologic Failure                0                0                0                3                2 
Non-compliance                0                0                0                1                1 
Lost to Follow-up                0                0                0                9                9 
Protocol Violation                0                0                0                1                0 
Withdrawal by Subject                0                0                0                4                3 
Pregnancy                0                0                0                3                0 
Participant Moved                0                0                0                1                1 
Sponsor Request                0                0                0                1                1 
Sponsor Terminated Site                0                0                0                3                3 
Other                0                0                0                1                0 
Physician Decision                0                0                0                0                1 
Participant Remained in Cuba                0                0                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ABC/3TC + ATV/r All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)

Baseline Measures
   ABC/3TC + ATV/r 
Overall Participants Analyzed 
[Units: Participants]
 515 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.3  (10.03) 
Gender 
[Units: Participants]
 
Female   86 
Male   429 
Race/Ethnicity, Customized 
[Units: Participants]
 
African American/African Heritage   167 
American Indian or Alaskan Native   9 
Asian - Central/South Asian Heritage   4 
Asian - East Asian Heritage   3 
Asian - Japanese Heritage   1 
Asian - South East Asian Heritage   3 
Native Hawaiian or Other Pacific Islander   1 
White - Arabic/North African Heritage   5 
White - White/Caucasian/European Heritage   316 
Mixed Race   6 
Number of participants with the indicated baseline HIV-RNA level [1] 
[Units: Participants]
 
HIV-1 RNA <100,000   227 
HIV-1 RNA 100,000-<250,000   143 
HIV-1 RNA 250,000-<500,000   73 
HIV-1 RNA >=500,000   72 
[1] HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid. HIV-1 viral load was measured as virus copies per milliliter (ml) at baseline.
Number of participants with the indicated Baseline CD4+ Cell Count [1] 
[Units: Participants]
 
CD4+ cells <50   69 
CD4+ cells 50-<200   190 
CD4+ cells >=200   256 
[1] A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts.
Number of participants with the indicated Center for Disease Control (CDC) Classification [1] 
[Units: Participants]
 
Asymptomatic HIV Infection   353 
Symptomatic (non-AIDS) condition   97 
AIDS   65 
[1] AIDS, Acquired Immunodeficiency Syndrome CDC classifications are Asymptomatic, Symptomatic, or AIDs.
Median Baseline CD4+ Cell Count 
[Units: Cells per cubic millimeter]
Median (Full Range)
 199 
 (19 to 754) 
Median Baseline HIV-1 RNA Level 
[Units: Log10 copies/ml]
Median (Full Range)
 5.076 
 (2.989 to 6.620) 


  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 84 Visit   [ Time Frame: Week 84 ]

2.  Secondary:   Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase   [ Time Frame: Baseline of Randomized Phase ]

3.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit   [ Time Frame: Week 36 ]

4.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit   [ Time Frame: Week 84 ]

5.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit   [ Time Frame: Week 144 ]

6.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit   [ Time Frame: Week 36 ]

7.  Secondary:   Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit   [ Time Frame: Week 84 ]

8.  Secondary:   Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit   [ Time Frame: Week 144 ]

9.  Secondary:   Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36   [ Time Frame: Week 36 ]

10.  Secondary:   Number of Participants Who Met the PDVF Criteria at Week 84   [ Time Frame: Week 84 ]

11.  Secondary:   Number of Participants Who Met the PDVF Criteria at Week 144   [ Time Frame: Week 144 ]

12.  Secondary:   Change From Baseline in HIV-1 RNA at Week 36   [ Time Frame: Baseline and Week 36 ]

13.  Secondary:   Change From Baseline in HIV-1 RNA at Week 84   [ Time Frame: Baseline and Week 84 ]

14.  Secondary:   Change From Baseline in HIV-1 RNA at Week 144   [ Time Frame: Baseline and Week 144 ]

15.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 36   [ Time Frame: Baseline and Week 36 ]

16.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 84   [ Time Frame: Baseline and Week 84 ]

17.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 144   [ Time Frame: Baseline and Week 144 ]

18.  Secondary:   Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36   [ Time Frame: Baseline through Week 36 ]

19.  Secondary:   Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84   [ Time Frame: Randomization at Week 36 through Week 84 ]

20.  Secondary:   Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144   [ Time Frame: Week 84 through Week 144 ]

21.  Secondary:   Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir   [ Time Frame: Baseline through Week 36 ]

22.  Secondary:   Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir   [ Time Frame: Randomization at Week 36 through Week 84 ]

23.  Secondary:   Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir   [ Time Frame: Week 84 through Week 144 ]

24.  Secondary:   Mean Percent Compliance at Week 36   [ Time Frame: Week 36 ]

25.  Secondary:   Mean Percent Compliance at Week 84   [ Time Frame: Week 84 ]

26.  Secondary:   Mean Percent Compliance at Week 144   [ Time Frame: Week 144 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at >=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is >=3% for at least one arm.

Frequency Threshold
Threshold above which other adverse events are reported   3  

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
ABC/3TC + ATV: Randomization Phase Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
ABC/3TC + ATV/r: Randomization Phase Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
ABC/3TC + ATV: Extension Phase Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Other Adverse Events
    ABC/3TC + ATV/r: Induction Phase   ABC/3TC + ATV: Randomization Phase   ABC/3TC + ATV/r: Randomization Phase   ABC/3TC + ATV: Extension Phase   ABC/3TC + ATV/r: Extension Phase
Total, other (not including serious) adverse events           
# participants affected / at risk   237/515 (46.02%)   116/210 (55.24%)   123/209 (58.85%)   123/189 (65.08%)   130/180 (72.22%) 
Eye disorders           
Conjunctivitis † 1           
# participants affected / at risk   7/515 (1.36%)   3/210 (1.43%)   4/209 (1.91%)   3/189 (1.59%)   6/180 (3.33%) 
Gastrointestinal disorders           
Diarrhoea † 1           
# participants affected / at risk   42/515 (8.16%)   24/210 (11.43%)   23/209 (11.00%)   25/189 (13.23%)   21/180 (11.67%) 
Nausea † 1           
# participants affected / at risk   24/515 (4.66%)   12/210 (5.71%)   10/209 (4.78%)   9/189 (4.76%)   12/180 (6.67%) 
Abdominal pain † 1           
# participants affected / at risk   4/515 (0.78%)   6/210 (2.86%)   3/209 (1.44%)   6/189 (3.17%)   4/180 (2.22%) 
Vomiting † 1           
# participants affected / at risk   9/515 (1.75%)   6/210 (2.86%)   4/209 (1.91%)   6/189 (3.17%)   3/180 (1.67%) 
General disorders           
Fatigue † 1           
# participants affected / at risk   4/515 (0.78%)   5/210 (2.38%)   8/209 (3.83%)   6/189 (3.17%)   8/180 (4.44%) 
Hepatobiliary disorders           
Blood bilirubin increased † 1           
# participants affected / at risk   40/515 (7.77%)   20/210 (9.52%)   22/209 (10.53%)   22/189 (11.64%)   24/180 (13.33%) 
Hyperbilirubinaemia † 1           
# participants affected / at risk   30/515 (5.83%)   14/210 (6.67%)   20/209 (9.57%)   14/189 (7.41%)   20/180 (11.11%) 
Infections and infestations           
Sinusitis † 1           
# participants affected / at risk   21/515 (4.08%)   15/210 (7.14%)   19/209 (9.09%)   19/189 (10.05%)   25/180 (13.89%) 
Bronchitis † 1           
# participants affected / at risk   18/515 (3.50%)   11/210 (5.24%)   22/209 (10.53%)   20/189 (10.58%)   22/180 (12.22%) 
Upper respiratory tract infection † 1           
# participants affected / at risk   16/515 (3.11%)   13/210 (6.19%)   16/209 (7.66%)   20/189 (10.58%)   19/180 (10.56%) 
Syphilis † 1           
# participants affected / at risk   7/515 (1.36%)   5/210 (2.38%)   7/209 (3.35%)   12/189 (6.35%)   10/180 (5.56%) 
Cellulitis † 1           
# participants affected / at risk   5/515 (0.97%)   6/210 (2.86%)   3/209 (1.44%)   9/189 (4.76%)   3/180 (1.67%) 
Influenza † 1           
# participants affected / at risk   9/515 (1.75%)   6/210 (2.86%)   4/209 (1.91%)   6/189 (3.17%)   6/180 (3.33%) 
Nasopharyngitis † 1           
# participants affected / at risk   7/515 (1.36%)   2/210 (0.95%)   6/209 (2.87%)   2/189 (1.06%)   8/180 (4.44%) 
Pneumonia † 1           
# participants affected / at risk   4/515 (0.78%)   0/210 (0.00%)   4/209 (1.91%)   1/189 (0.53%)   6/180 (3.33%) 
Investigations           
Blood Cholesterol increased † 1           
# participants affected / at risk   8/515 (1.55%)   7/210 (3.33%)   7/209 (3.35%)   8/189 (4.23%)   7/180 (3.89%) 
Lipase increased † 1           
# participants affected / at risk   4/515 (0.78%)   8/210 (3.81%)   1/209 (0.48%)   9/189 (4.76%)   1/180 (0.56%) 
Blood triglycerides increased † 1           
# participants affected / at risk   8/515 (1.55%)   4/210 (1.90%)   4/209 (1.91%)   6/189 (3.17%)   6/180 (3.33%) 
Low density lipoprotein increased † 1           
# participants affected / at risk   4/515 (0.78%)   4/210 (1.90%)   3/209 (1.44%)   6/189 (3.17%)   2/180 (1.11%) 
Metabolism and nutrition disorders           
Hyperlipidaemia † 1           
# participants affected / at risk   5/515 (0.97%)   4/210 (1.90%)   4/209 (1.91%)   3/189 (1.59%)   8/180 (4.44%) 
Hypercholesterolaemia † 1           
# participants affected / at risk   6/515 (1.17%)   5/210 (2.38%)   1/209 (0.48%)   6/189 (3.17%)   1/180 (0.56%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1           
# participants affected / at risk   5/515 (0.97%)   7/210 (3.33%)   0/209 (0.00%)   11/189 (5.82%)   3/180 (1.67%) 
Pain in extremity † 1           
# participants affected / at risk   6/515 (1.17%)   3/210 (1.43%)   3/209 (1.44%)   8/189 (4.23%)   6/180 (3.33%) 
Back pain † 1           
# participants affected / at risk   10/515 (1.94%)   6/210 (2.86%)   3/209 (1.44%)   8/189 (4.23%)   5/180 (2.78%) 
Nervous system disorders           
Headache † 1           
# participants affected / at risk   16/515 (3.11%)   10/210 (4.76%)   10/209 (4.78%)   9/189 (4.76%)   9/180 (5.00%) 
Psychiatric disorders           
Depression † 1           
# participants affected / at risk   18/515 (3.50%)   11/210 (5.24%)   10/209 (4.78%)   11/189 (5.82%)   15/180 (8.33%) 
Insomnia † 1           
# participants affected / at risk   17/515 (3.30%)   6/210 (2.86%)   11/209 (5.26%)   11/189 (5.82%)   13/180 (7.22%) 
Anxiety † 1           
# participants affected / at risk   12/515 (2.33%)   9/210 (4.29%)   8/209 (3.83%)   10/189 (5.29%)   7/180 (3.89%) 
Skin and subcutaneous tissue disorders           
Rash † 1           
# participants affected / at risk   23/515 (4.47%)   10/210 (4.76%)   7/209 (3.35%)   10/189 (5.29%)   7/180 (3.89%) 
Vascular disorders           
Hypertension † 1           
# participants affected / at risk   1/515 (0.19%)   1/210 (0.48%)   4/209 (1.91%)   2/189 (1.06%)   8/180 (4.44%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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
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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:
L Ross, E Dejesus, M Potter, A LaMarca, D Murphy, I Melendez-Rivera, D Ward, P Wannamaker, J Uy, L Patel, H Amrine-Madsen, J Horton. Epidemiological and Genotypic Clustering of HIV infection within North America During 2007 International HIV & Hepatitis Drug Resistance Workshop & Curative Strategies, 8-12 June 2010, Dubrovnik, Croatia, Poster 150.
• L Ross, K Squires, B Young, E DeJesus, N Bellos, D Murphy, A Rachlis, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Genotypic Screening Impact in ARIES [Atazanavir (ATV) + Ritonavir (/r) + Abacavir/Lamivudine (ABC/3TC) for 36 Weeks Followed By Randomization to ATV +ABC/3TC or ATV/r + ABC/3TC for 48 Wks in HIV-infected, ART Naïve Patients] :Low Rates of Virologic Failure. The 19th Annual Canadian Conference on HIV/AIDS Research, 13-16 May 2010, Saskatoon, Canada. Poster P-169.
K Squires, E DeJesus, N Bellos, D Ward, D Murphy, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Sustained Virologic Efficacy of Atazanavir (ATV) Versus Atazanavir/Ritonavir (ATV/r), each in Combination with Abacavir/Lamivudine (ABC/3TC) over 120 Weeks: the ARIES Trial. 48th ICAAC; September 12-15, 2010, Boston, MA. Poster H-204.
K Squires, B Young, E DeJesus, N Bellos, D Murphy, D Sutherland-Phillips, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Atazanavir/Ritonavir (ATV/r) + Abacavir/Lamivudine (ABC/3TC) in Antiretroviral (ART)-Naive HIV-1 Infected HLA-B*5701 Negative Subjects Demonstrates Efficacy and Safety: the ARIES Trial. 48th ICAAC; October 25-28, 2008, Washington, DC. Poster H-1250a.
K Squires, B Young, E DeJesus, N Bellos, D Murphy, D Sutherland-Phillips, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Similar Efficacy and Tolerability of Atazanavir (ATV) Compared to ATV/Ritonavir (RTV, r), Each in Combination with Abacavir/Lamivudine (ABC/3TC), after Initial Suppression with ABC/3TC + ATV/r in HIV-1 Infected Patients: 84 Week Results of the ARIES Trial. 5th IAS Conference; Cape Town, South Africa. Abstract WELBB103

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00440947     History of Changes
Other Study ID Numbers: EPZ108859
Study First Received: February 23, 2007
Results First Received: May 19, 2011
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration