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50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.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  
Unknown                 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  
Number of Participants  
[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  
Number of participants with the indicated Baseline CD4+ Cell Count [2]
[units: participants]
 
CD4+ cells <50     69  
CD4+ cells 50-<200     190  
CD4+ cells >=200     256  
Number of participants with the indicated Center for Disease Control (CDC) Classification [3]
[units: participants]
 
Asymptomatic HIV Infection     353  
Symptomatic (non-AIDS) condition     97  
AIDS     65  
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 )  
[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.
[2] A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts.
[3] AIDS, Acquired Immunodeficiency Syndrome CDC classifications are Asymptomatic, Symptomatic, or AIDs.



  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
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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.

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

Serious 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, serious adverse events            
# participants affected / at risk     39/515 (7.57%)     22/210 (10.48%)     22/209 (10.53%)     24/189 (12.70%)     24/180 (13.33%)  
Cardiac disorders            
Angina unstable † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Ear and labyrinth disorders            
Vertigo † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Endocrine disorders            
Hyperparathyroidism † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Eye disorders            
Vision blurred † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Gastrointestinal disorders            
Abdominal pain † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Colitis † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Diarrhoea † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Gastritis † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Nausea † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     2/189 (1.06%)     0/180 (0.00%)  
Pancreatitis † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     1/189 (0.53%)     1/180 (0.56%)  
Vomiting † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     2/189 (1.06%)     0/180 (0.00%)  
Rectal haemorrhage † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Small intestinal obstruction † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
General disorders            
Chest pain † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Non-cardiac chest pain † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     2/189 (1.06%)     0/180 (0.00%)  
Pyrexia † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     1/209 (0.48%)     1/189 (0.53%)     0/180 (0.00%)  
Hepatobiliary disorders            
Cholecystitis † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Hepatic failure † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Hepatotoxicity † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Hyperbilirubinaemia † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Immune system disorders            
Drug hypersensitivity † 1          
# participants affected / at risk     5/515 (0.97%)     2/210 (0.95%)     3/209 (1.44%)     1/189 (0.53%)     4/180 (2.22%)  
Hypersensitivity † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Infections and infestations            
Appendicitis † 1          
# participants affected / at risk     3/515 (0.58%)     2/210 (0.95%)     1/209 (0.48%)     1/189 (0.53%)     2/180 (1.11%)  
Appendicitis, perforated † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     1/209 (0.48%)     1/189 (0.53%)     1/180 (0.56%)  
Pneumocystis jiroveci pneumonia † 1          
# participants affected / at risk     2/515 (0.39%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Pneumonia † 1          
# participants affected / at risk     2/515 (0.39%)     0/210 (0.00%)     1/209 (0.48%)     1/189 (0.53%)     1/180 (0.56%)  
Bronchitis † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     2/189 (1.06%)     0/180 (0.00%)  
Cellulitis † 1          
# participants affected / at risk     1/515 (0.19%)     2/210 (0.95%)     0/209 (0.00%)     4/189 (2.12%)     0/180 (0.00%)  
Peritoneal infection † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Genital herpes † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Shigella infection † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Clostridium difficile colitis † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Gastroenteritis viral † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Lobar pneumonia † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Meningitis aseptic † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Proctitis gonococcal † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     0/180 (0.00%)  
Sinusitis † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Staphylococcal infection † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Viral upper respiratory tract infection † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Injury, poisoning and procedural complications            
Alcohol poisoning † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     1/180 (0.56%)  
Ankle fracture † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Contusion † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Fall † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Foot fracture † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Post lumbar puncture syndrome † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Therapeutic agent toxicity † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Investigations            
Hepatic enzyme increased † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Metabolism and nutrition disorders            
Hyperglycaemia † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Metabolic acidosis † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Musculoskeletal and connective tissue disorders            
Rhabdomyolysis † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)            
Syncope † 1          
# participants affected / at risk     2/515 (0.39%)     1/210 (0.48%)     1/209 (0.48%)     1/189 (0.53%)     1/180 (0.56%)  
Burkitt’s lymphoma † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Diffuse large B-cell lymphoma † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     0/180 (0.00%)  
Castleman’s disease † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Pharyngeal neoplasm † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Squamous cell carcinoma † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     0/180 (0.00%)  
Uterine leiomyoma † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Cervix carcinoma stage II † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Lung adenocarcinoma † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Nervous system disorders            
Convulsion † 1          
# participants affected / at risk     2/515 (0.39%)     1/210 (0.48%)     1/209 (0.48%)     1/189 (0.53%)     0/180 (0.00%)  
Cerebrovascular accident † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     2/209 (0.96%)     0/189 (0.00%)     2/180 (1.11%)  
Cerebral infarction † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Headache † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Transient ischaemic attack † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     0/180 (0.00%)  
Pregnancy, puerperium and perinatal conditions            
Abortion spontaneous † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Psychiatric disorders            
Depression † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Mental disorder † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Suicidal ideation † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     1/209 (0.48%)     1/189 (0.53%)     1/180 (0.56%)  
Suicide attempt † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Renal and urinary disorders            
Nephrolithiasis † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Renal failure † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Respiratory, thoracic and mediastinal disorders            
Acute respiratory failure † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Chronic obstructive pulmonary disease † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Dyspnoea † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Pneumonia aspiration † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Pulmonary embolism † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Skin and subcutaneous tissue disorders            
Hypoaesthesia facial † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Angioedema † 1          
# participants affected / at risk     0/515 (0.00%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Vascular disorders            
Peripheral vascular disorder † 1          
# participants affected / at risk     0/515 (0.00%)     0/210 (0.00%)     1/209 (0.48%)     0/189 (0.00%)     1/180 (0.56%)  
Deep vein thrombosis † 1          
# participants affected / at risk     1/515 (0.19%)     0/210 (0.00%)     0/209 (0.00%)     0/189 (0.00%)     1/180 (0.56%)  
Hypertensive crisis † 1          
# participants affected / at risk     1/515 (0.19%)     1/210 (0.48%)     0/209 (0.00%)     1/189 (0.53%)     0/180 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




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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.


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


Publications:
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:

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