Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects.

All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus I
HIV Infection
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.


Secondary Outcome Measures:
  • Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase [ Time Frame: Baseline of Randomized Phase ] [ Designated as safety issue: No ]
    The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.

  • Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.

  • Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.

  • Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.

  • Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.

  • Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.

  • Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.

  • Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.

  • Number of Participants Who Met the PDVF Criteria at Week 84 [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.

  • Number of Participants Who Met the PDVF Criteria at Week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.

  • Change From Baseline in HIV-1 RNA at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.

  • Change From Baseline in HIV-1 RNA at Week 84 [ Time Frame: Baseline and Week 84 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.

  • Change From Baseline in HIV-1 RNA at Week 144 [ Time Frame: Baseline and Week 144 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.

  • Change From Baseline in CD4+ Cell Count at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.

  • Change From Baseline in CD4+ Cell Count at Week 84 [ Time Frame: Baseline and Week 84 ] [ Designated as safety issue: No ]
    A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.

  • Change From Baseline in CD4+ Cell Count at Week 144 [ Time Frame: Baseline and Week 144 ] [ Designated as safety issue: No ]
    A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.

  • 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 ] [ Designated as safety issue: No ]
    A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.

  • Mean Percent Compliance at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.

  • Mean Percent Compliance at Week 84 [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.

  • Mean Percent Compliance at Week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.


Enrollment: 515
Study Start Date: March 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Simplification
Atazanavir (ATV) 400 mg QD + abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen.
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen
Continuation
Atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD + abacavir (ABC) 600mg/lamivuidine (3TC )300 mg FDC QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen.
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen

Detailed Description:

Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B*5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subject is ≥ 18 years of age and has documented evidence of HIV-1 infection. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.)
  • Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI).
  • Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL by Roche COBAS AMPLICOR™ (Version 1.5) method at screening (if no other documentation of HIV infection is available, a positive result here may serve as documentation of HIV infection for this study).
  • Subject is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria:

  • Subject is HLA-B*5701 positive.
  • Subject testing positive for Hepatitis B or both Hepatitis B and Hepatitis C at screening (+ HbsAg)
  • Genotyping results performed at the screening indicate that the subject has any of the following mutations at the reverse transcriptase (RT) enzyme: K65R, L74V, or Y115F, or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, or ≥ 3 of the following protease mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90.
  • Women who are pregnant or breastfeeding.
  • Subject has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.
  • Subject is, in the opinion of the investigator, unable to complete the 84-week dosing period and protocol evaluations and assessments.
  • Subject has ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.
  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
  • Subject suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction (including known, clinically significant cardiac conduction system disease, severe first degree atrioventricular block [PR interval > 0.26 seconds], second or third-degree atrioventricular block), which in the opinion of the investigator would compromise the safety of the subject.
  • Subject has pre-existing mental, physical, or substance abuse disorder, which in the opinion of the investigator would interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
  • Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which may interfere with drug absorption or render the subject unable to take oral medication.
  • Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration.
  • Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to screening, or subject had received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled corticosteroids are eligible for enrollment.
  • Creatinine clearance <50 mL/min via the Cockroft-Gault method [Cockroft, 1976].
  • Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
  • Hypersensitivity to any component of the study drugs.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
  • Total bilirubin > 1.5 times the upper limit of normal (ULN).
  • Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality would exclude a subject from study participation.
  • Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.
  • Enrolled in one or more investigational drug protocols, which may have impacted HIV-1 RNA suppression.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  • Subjects requiring concomitant administration of proton pump inhibitors.
  • Subjects who require treatment with the prohibited medications within 28 days of commencement of investigational product, or an anticipated need during the study.

Eligibility Criteria for Treatment Extension Phase:

-Subjects will be eligible to continue in the treatment extension phase (Weeks 84 to 144) if they have successfully completed the 84-week study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440947

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85012
United States, California
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90022
GSK Investigational Site
Newport Beach, California, United States, 92663
GSK Investigational Site
Oakland, California, United States, 94609
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
GSK Investigational Site
Glastonbury, Connecticut, United States, 06033
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
GSK Investigational Site
Washington, District of Columbia, United States, 20036
GSK Investigational Site
Washington, District of Columbia, United States, 20007
GSK Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Pierce, Florida, United States, 34982
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33306
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Orlando, Florida, United States, 32803
GSK Investigational Site
Plantation, Florida, United States, 33317
GSK Investigational Site
Sarasota, Florida, United States, 34243
GSK Investigational Site
Tampa, Florida, United States, 33602
GSK Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30309
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Maywood, Illinois, United States, 60153
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
GSK Investigational Site
Minneapolis, Minnesota, United States, 55415
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Newark, New Jersey, United States, 07102
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
GSK Investigational Site
Toledo, Ohio, United States, 43614
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 2906
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
El Paso, Texas, United States, 79925
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Galveston, Texas, United States, 77555
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77057
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Longview, Texas, United States, 75605
United States, Virginia
GSK Investigational Site
Annandale, Virginia, United States, 22003
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1L6
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2X 2P4
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00717
GSK Investigational Site
Ponce, Puerto Rico, 00731
GSK Investigational Site
San Juan, Puerto Rico, 00910
GSK Investigational Site
San Juan, Puerto Rico, 00909-1711
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

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

Additional 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

Keywords provided by ViiV Healthcare:
NORVIR
ARIES
EPZICOM
REYATAZ
HIV
simplification
Antiretroviral-naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Atazanavir
Lamivudine
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014