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Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study) (INDUMA)

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ClinicalTrials.gov Identifier: NCT00207142
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : January 7, 2010
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Atazanavir + 2 NRTIs
Drug: Atazanavir + Ritonavir + 2 NRTIs
Enrollment 252

Recruitment Details  
Pre-assignment Details 288 subjects were enrolled, of which 36 did not start Induction Phase Therapy (22 did not meet study criteria, 6 withdrew consent, 4 lost to follow-up, 3 had missing information, and 1 for investigator's decision).
Arm/Group Title Induction Treatment Maintenance Treatment: Switch Regimen Maintenance Treatment: Continuation Regimen Rescue Treatment
Hide Arm/Group Description Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI). Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI). Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
Period Title: Induction Phase
Started 252 0 0 0
Completed 222 [1] 0 0 0
Not Completed 30 0 0 0
Reason Not Completed
Adverse Event             9             0             0             0
Death             1             0             0             0
Lack of Efficacy             1             0             0             0
Lost to Follow-up             5             0             0             0
Physician Decision             2             0             0             0
Poor/noncompliance             2             0             0             0
Pregnancy             1             0             0             0
Subject no longer meets study criteria             3             0             0             0
Withdrawal by Subject             4             0             0             0
Incarceration             1             0             0             0
Missing lab data             1             0             0             0
[1]
Subjects randomized into Maintenance Phase=172 (87 ATV +85 ATV/RTV); Rescue Phase subjects=50
Period Title: Maintenance Phase/Rescue Phase
Started 0 87 85 50
Completed 0 78 72 41
Not Completed 0 9 13 9
Reason Not Completed
Adverse Event             0             1             4             1
Lost to Follow-up             0             1             1             2
RTV intake impossible             0             0             1             0
Poor/noncompliance             0             3             2             3
Pregnancy             0             2             2             0
Subject no longer meets study criteria             0             0             1             0
Withdrawal by Subject             0             2             2             1
Death             0             0             0             1
Lack of Efficacy             0             0             0             1
Arm/Group Title Randomized Subjects: Switch Regimen Randomized Subjects: Continuation Regimen Nonrandomized Subjects Total
Hide Arm/Group Description ATV 400 mg QD + 2 NRTIs ATV 300 mg + RTV 100 mg QD + 2 NRTIs All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs Total of all reporting groups
Overall Number of Baseline Participants 87 85 80 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 87 participants 85 participants 80 participants 252 participants
35
(21 to 66)
35
(19 to 70)
36
(20 to 71)
36
(19 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 80 participants 252 participants
Female
22
  25.3%
24
  28.2%
16
  20.0%
62
  24.6%
Male
65
  74.7%
61
  71.8%
64
  80.0%
190
  75.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 80 participants 252 participants
White 73 70 66 209
Black 14 14 11 39
Other 0 1 3 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 80 participants 252 participants
Europe 68 68 60 196
Russian Federation 19 17 20 56
Hepatitis B or C  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 80 participants 252 participants
Hepatitis B/C positive 16 20 23 59
Hepatitis B/C negative 71 65 57 193
Baseline CD4  
Median (Full Range)
Unit of measure:  Cells/mm3
Number Analyzed 87 participants 85 participants 80 participants 252 participants
255
(50 to 660)
265
(64 to 490)
227
(2 to 876)
245
(2 to 876)
Baseline HIV-1 RNA  
Median (Full Range)
Unit of measure:  log10c/mL
Number Analyzed 87 participants 85 participants 80 participants 252 participants
4.85
(3.51 to 5.88)
4.86
(3.58 to 5.88)
5.46
(3.74 to 5.88)
4.95
(3.51 to 5.88)
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
Hide Description Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.
Time Frame From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: Percentage of participants
78 75
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch Regimen, Continuation Regimen
Comments The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.9
Confidence Interval 95%
-9.8 to 15.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
Hide Description Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.
Time Frame From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: Percentage of participants
86 81
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch Regimen, Continuation Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal Approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 5.0
Confidence Interval 95%
-6.0 to 16.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Hide Description Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
Time Frame Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: Proportion of participants
Proportion by Week 6-8 0.9655 0.9412
Proportion by Week 14-16 0.9655 0.9176
Proportion by Week 22-24 0.9540 0.9059
Proportion by Week 30-32 0.9310 0.8824
Proportion by Week 38-40 0.8506 0.8343
Proportion by Week 46-48 0.8273 0.8176
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch Regimen, Continuation Regimen
Comments Covariate in the model: treatment regimen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.97
Confidence Interval 95%
0.50 to 1.88
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Hide Description Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
Time Frame Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: Proportion of participants
Proportion by Week 6-8 0.9412 0.9885
Proportion by Week 14-16 0.9176 0.9885
Proportion by Week 22-24 0.9059 0.9770
Proportion by Week 30-32 0.8824 0.9540
Proportion by Week 38-40 0.8585 0.8966
Proportion by Week 46-48 0.8585 0.8823
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch Regimen, Continuation Regimen
Comments Covariate in the model: treatment regimen
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.84
Confidence Interval 95%
0.37 to 1.90
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
Hide Description Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.
Time Frame End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-randomized population (as-randomized refers to the treatment regimen assigned at randomization). Analysis uses observed values (participants included are those with CD4 measurements at end of Induction Phase and at Week 48 of Maintenance Phase).
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 76 68
Mean (Standard Error)
Unit of Measure: cells/mm3
100  (14.7) 92  (18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch Regimen, Continuation Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in means at Week 48
Estimated Value 7
Confidence Interval 95%
-38 to 53
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
Hide Description Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.
Time Frame Baseline, Week 24 of Induction Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).
Arm/Group Title Randomized Subjects Nonrandomized Subjects Total
Hide Arm/Group Description:
All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 155 49 204
Mean (Standard Error)
Unit of Measure: cells/mm3
170  (10.0) 201  (18.5) 177  (8.8)
7.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
Hide Description Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.
Time Frame Baseline, Week 48 of Rescue Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).
Arm/Group Title Rescue Treatment
Hide Arm/Group Description:
Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 38
Mean (Standard Error)
Unit of Measure: cells/mm3
313  (26.6)
8.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
Hide Description Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.
Time Frame Baseline, Week 24 of Induction Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).
Arm/Group Title Randomized Subjects Nonrandomized Subjects Total
Hide Arm/Group Description:
All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 151 47 198
Mean (Standard Error)
Unit of Measure: log10 c/mL
-3.16  (0.046) -3.35  (0.135) -3.21  (0.048)
9.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
Hide Description Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.
Time Frame \Baseline, Week 48 of Rescue Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)
Arm/Group Title Rescue Treatment
Hide Arm/Group Description:
Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: log10 c/mL
-3.71  (0.078)
10.Secondary Outcome
Title Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Hide Description Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.
Time Frame Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rescue Treatment
Hide Arm/Group Description:
Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Participants
Suppression Maintained Through Week 48 29
Suppression, then Virologic Rebound at/before Wk48 7
Discontinuation Before Week 48 8
Viral Suppression Never Achieved 6
11.Secondary Outcome
Title Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Hide Description Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.
Time Frame Baseline, Week 48 of Rescue Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rescue Treatment
Hide Arm/Group Description:
Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Participants
Suppression Maintained Through Week 48 39
Suppression, then Virologic Rebound at/before Wk48 2
Discontinuation Before Week 48 9
Viral Suppression Never Achieved 0
12.Secondary Outcome
Title Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Hide Description Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
Time Frame Week 16-18, Week 24-26, Week 38-40, Week 64-66
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Subjects Nonrandomized Subjects
Hide Arm/Group Description:
All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
Overall Number of Participants Analyzed 172 80
Measure Type: Number
Unit of Measure: Participants
Number of Participants Suppressed by Wk 16-18 131 3
Number of Participants Suppressed by Wk 24-26 171 5
Number of Participants Suppressed by Wk 38-40 172 31
Number of Participants Suppressed by Wk 64-66 172 42
13.Secondary Outcome
Title Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
Hide Description Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
Time Frame Week 16-18, Week 24-26, Week 30-32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Subjects Nonrandomized Subjects
Hide Arm/Group Description:
All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
Overall Number of Participants Analyzed 172 80
Measure Type: Number
Unit of Measure: Participants
Number of Participants Suppressed by Week 16-18 168 39
Number of Participants Suppressed by Wk 24-26 171 54
Number of Participants Suppressed by Wk 30-32 172 55
14.Secondary Outcome
Title Summary of Adverse Events During Induction Phase
Hide Description Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of Induction Phase study therapy.
Arm/Group Title Randomized Subjects Nonrandomized Subjects Total
Hide Arm/Group Description:
All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 172 80 252
Measure Type: Number
Unit of Measure: Participants
Deaths 0 3 3
SAEs 7 9 16
SAEs related to study therapy 0 2 2
AEs leading to discontinuation 0 9 9
15.Secondary Outcome
Title Summary of Adverse Events During Maintenance Phase
Hide Description Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase).
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400 mg QD + 2 NRTIs
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0
Serious Adverse Events (SAEs) 4 3
SAEs related to study therapy 0 0
AEs leading to discontinuation 1 4
16.Secondary Outcome
Title Summary of Adverse Events During Rescue Phase
Hide Description Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of Rescue Phase study therapy
Arm/Group Title Rescue Treatment
Hide Arm/Group Description:
Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Participants
Deaths 1
SAEs 2
SAEs related to study therapy 0
AEs leading to discontinuation 1
17.Secondary Outcome
Title Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
Hide Description Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.
Time Frame Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase). Analysis used last observation carried forward (LOCF) to replace missing values.
Arm/Group Title Switch Regimen Continuation Regimen
Hide Arm/Group Description:
ATV 400mg QD + 2NRTIs
ATV 300mg + RTV 100mg QD + 2NRTIs
Overall Number of Participants Analyzed 81 77
Mean (95% Confidence Interval)
Unit of Measure: percent change
Total Cholesterol
-4.7
(-8.28 to -1.02)
1.4
(-1.88 to 4.78)
HDL Cholesterol
3.7
(-0.86 to 8.42)
0.8
(-4.24 to 6.12)
LDL Cholesterol
-0.7
(-6.7 to 5.8)
-2.1
(-7.10 to 3.26)
Triglycerides
-27.0
(-33.21 to -20.19)
9.8
(-1.35 to 22.23)
Non-HDL Cholesterol
-7.4
(-12.15 to -2.48)
1.1
(-3.34 to 5.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Switch Regimen Continuation Regimen Non-Randomized Participants
Hide Arm/Group Description ATV 400 mg QD + 2 NRTIs ATV 300 mg + RTV 100 mg QD + 2 NRTIs All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
All-Cause Mortality
Switch Regimen Continuation Regimen Non-Randomized Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Switch Regimen Continuation Regimen Non-Randomized Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/87 (8.05%)   5/85 (5.88%)   11/80 (13.75%) 
Blood and lymphatic system disorders       
ANAEMIA  1  1/87 (1.15%)  0/85 (0.00%)  1/80 (1.25%) 
PANCYTOPENIA  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Gastrointestinal disorders       
VOMITING  1  1/87 (1.15%)  0/85 (0.00%)  0/80 (0.00%) 
DIARRHOEA  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
DUODENITIS  1  1/87 (1.15%)  0/85 (0.00%)  0/80 (0.00%) 
HAEMORRHOIDS  1  1/87 (1.15%)  0/85 (0.00%)  0/80 (0.00%) 
INGUINAL HERNIA  1  2/87 (2.30%)  0/85 (0.00%)  0/80 (0.00%) 
PANCREATITIS ACUTE  1  0/87 (0.00%)  0/85 (0.00%)  2/80 (2.50%) 
General disorders       
MULTI-ORGAN FAILURE  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Hepatobiliary disorders       
CHOLELITHIASIS  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Infections and infestations       
PNEUMONIA  1  1/87 (1.15%)  1/85 (1.18%)  2/80 (2.50%) 
MENINGITIS  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
GASTROENTERITIS  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
APPENDICEAL ABSCESS  1  0/87 (0.00%)  1/85 (1.18%)  0/80 (0.00%) 
PNEUMOCYSTIS JIROVECI PNEUMONIA  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Injury, poisoning and procedural complications       
OVERDOSE  1  0/87 (0.00%)  1/85 (1.18%)  0/80 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders       
MUSCLE SPASMS  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
OSTEOARTHRITIS  1  0/87 (0.00%)  1/85 (1.18%)  0/80 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
NON-HODGKIN'S LYMPHOMA  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Psychiatric disorders       
ANXIETY  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
DRUG DEPENDENCE  1  1/87 (1.15%)  0/85 (0.00%)  0/80 (0.00%) 
SUICIDE ATTEMPT  1  0/87 (0.00%)  0/85 (0.00%)  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders       
LUNG DISORDER  1  0/87 (0.00%)  1/85 (1.18%)  0/80 (0.00%) 
PLEURITIC PAIN  1  1/87 (1.15%)  0/85 (0.00%)  0/80 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Switch Regimen Continuation Regimen Non-Randomized Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   72/87 (82.76%)   75/85 (88.24%)   52/80 (65.00%) 
Eye disorders       
OCULAR ICTERUS  1  15/87 (17.24%)  18/85 (21.18%)  6/80 (7.50%) 
Gastrointestinal disorders       
NAUSEA  1  10/87 (11.49%)  13/85 (15.29%)  12/80 (15.00%) 
VOMITING  1  2/87 (2.30%)  5/85 (5.88%)  5/80 (6.25%) 
DIARRHOEA  1  14/87 (16.09%)  14/85 (16.47%)  5/80 (6.25%) 
ABDOMINAL PAIN  1  7/87 (8.05%)  9/85 (10.59%)  2/80 (2.50%) 
ABDOMINAL PAIN UPPER  1  1/87 (1.15%)  5/85 (5.88%)  4/80 (5.00%) 
General disorders       
PYREXIA  1  5/87 (5.75%)  5/85 (5.88%)  1/80 (1.25%) 
ASTHENIA  1  7/87 (8.05%)  10/85 (11.76%)  8/80 (10.00%) 
INFLUENZA LIKE ILLNESS  1  3/87 (3.45%)  6/85 (7.06%)  3/80 (3.75%) 
Hepatobiliary disorders       
JAUNDICE  1  4/87 (4.60%)  9/85 (10.59%)  3/80 (3.75%) 
HYPERBILIRUBINAEMIA  1  5/87 (5.75%)  5/85 (5.88%)  5/80 (6.25%) 
Infections and infestations       
SINUSITIS  1  2/87 (2.30%)  5/85 (5.88%)  0/80 (0.00%) 
BRONCHITIS  1  8/87 (9.20%)  7/85 (8.24%)  2/80 (2.50%) 
PHARYNGITIS  1  6/87 (6.90%)  1/85 (1.18%)  1/80 (1.25%) 
NASOPHARYNGITIS  1  5/87 (5.75%)  7/85 (8.24%)  7/80 (8.75%) 
VIRAL INFECTION  1  3/87 (3.45%)  2/85 (2.35%)  5/80 (6.25%) 
RESPIRATORY TRACT INFECTION  1  2/87 (2.30%)  1/85 (1.18%)  4/80 (5.00%) 
Investigations       
BLOOD BILIRUBIN INCREASED  1  32/87 (36.78%)  33/85 (38.82%)  17/80 (21.25%) 
ALANINE AMINOTRANSFERASE INCREASED  1  8/87 (9.20%)  8/85 (9.41%)  7/80 (8.75%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  7/87 (8.05%)  3/85 (3.53%)  7/80 (8.75%) 
Metabolism and nutrition disorders       
HYPERTRIGLYCERIDAEMIA  1  2/87 (2.30%)  1/85 (1.18%)  4/80 (5.00%) 
Nervous system disorders       
HEADACHE  1  11/87 (12.64%)  13/85 (15.29%)  8/80 (10.00%) 
Psychiatric disorders       
DEPRESSION  1  5/87 (5.75%)  2/85 (2.35%)  3/80 (3.75%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  4/87 (4.60%)  6/85 (7.06%)  1/80 (1.25%) 
RHINORRHOEA  1  3/87 (3.45%)  6/85 (7.06%)  5/80 (6.25%) 
Skin and subcutaneous tissue disorders       
RASH  1  3/87 (3.45%)  7/85 (8.24%)  4/80 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00207142     History of Changes
Other Study ID Numbers: AI424-136
First Submitted: September 16, 2005
First Posted: September 21, 2005
Results First Submitted: June 2, 2009
Results First Posted: January 7, 2010
Last Update Posted: January 12, 2010