Trial Outcomes & Findings for Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study) (NCT NCT00207142)
NCT ID: NCT00207142
Last Updated: 2010-01-12
Results Overview
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.
COMPLETED
PHASE4
252 participants
From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
2010-01-12
Participant Flow
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).
Participant milestones
| Measure |
Induction Treatment
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
|
Maintenance Treatment: Switch Regimen
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).
|
Maintenance Treatment: Continuation Regimen
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).
|
Rescue Treatment
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).
|
|---|---|---|---|---|
|
Induction Phase
STARTED
|
252
|
0
|
0
|
0
|
|
Induction Phase
COMPLETED
|
222
|
0
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
30
|
0
|
0
|
0
|
|
Maintenance Phase/Rescue Phase
STARTED
|
0
|
87
|
85
|
50
|
|
Maintenance Phase/Rescue Phase
COMPLETED
|
0
|
78
|
72
|
41
|
|
Maintenance Phase/Rescue Phase
NOT COMPLETED
|
0
|
9
|
13
|
9
|
Reasons for withdrawal
| Measure |
Induction Treatment
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
|
Maintenance Treatment: Switch Regimen
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).
|
Maintenance Treatment: Continuation Regimen
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).
|
Rescue Treatment
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).
|
|---|---|---|---|---|
|
Induction Phase
Adverse Event
|
9
|
0
|
0
|
0
|
|
Induction Phase
Death
|
1
|
0
|
0
|
0
|
|
Induction Phase
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Induction Phase
Lost to Follow-up
|
5
|
0
|
0
|
0
|
|
Induction Phase
Physician Decision
|
2
|
0
|
0
|
0
|
|
Induction Phase
Poor/noncompliance
|
2
|
0
|
0
|
0
|
|
Induction Phase
Pregnancy
|
1
|
0
|
0
|
0
|
|
Induction Phase
Subject no longer meets study criteria
|
3
|
0
|
0
|
0
|
|
Induction Phase
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
|
Induction Phase
Incarceration
|
1
|
0
|
0
|
0
|
|
Induction Phase
Missing lab data
|
1
|
0
|
0
|
0
|
|
Maintenance Phase/Rescue Phase
Adverse Event
|
0
|
1
|
4
|
1
|
|
Maintenance Phase/Rescue Phase
Lost to Follow-up
|
0
|
1
|
1
|
2
|
|
Maintenance Phase/Rescue Phase
RTV intake impossible
|
0
|
0
|
1
|
0
|
|
Maintenance Phase/Rescue Phase
Poor/noncompliance
|
0
|
3
|
2
|
3
|
|
Maintenance Phase/Rescue Phase
Pregnancy
|
0
|
2
|
2
|
0
|
|
Maintenance Phase/Rescue Phase
Subject no longer meets study criteria
|
0
|
0
|
1
|
0
|
|
Maintenance Phase/Rescue Phase
Withdrawal by Subject
|
0
|
2
|
2
|
1
|
|
Maintenance Phase/Rescue Phase
Death
|
0
|
0
|
0
|
1
|
|
Maintenance Phase/Rescue Phase
Lack of Efficacy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
Baseline characteristics by cohort
| Measure |
Randomized Subjects: Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Randomized Subjects: Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Nonrandomized Subjects
n=80 Participants
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
35 years
n=5 Participants
|
35 years
n=7 Participants
|
36 years
n=5 Participants
|
36 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
60 participants
n=5 Participants
|
196 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Hepatitis B or C
Hepatitis B/C positive
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Hepatitis B or C
Hepatitis B/C negative
|
71 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Baseline CD4
|
255 cells/mm3
n=5 Participants
|
265 cells/mm3
n=7 Participants
|
227 cells/mm3
n=5 Participants
|
245 cells/mm3
n=4 Participants
|
|
Baseline HIV-1 RNA
|
4.85 log10c/mL
n=5 Participants
|
4.86 log10c/mL
n=7 Participants
|
5.46 log10c/mL
n=5 Participants
|
4.95 log10c/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance PhasePopulation: As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).
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.
Outcome measures
| Measure |
Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
|
78 Percentage of participants
|
75 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance PhasePopulation: As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)
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.
Outcome measures
| Measure |
Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
|
86 Percentage of participants
|
81 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48Population: As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).
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.
Outcome measures
| Measure |
Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 6-8
|
0.9655 Proportion of participants
|
0.9412 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 14-16
|
0.9655 Proportion of participants
|
0.9176 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 22-24
|
0.9540 Proportion of participants
|
0.9059 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 30-32
|
0.9310 Proportion of participants
|
0.8824 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 38-40
|
0.8506 Proportion of participants
|
0.8343 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 46-48
|
0.8273 Proportion of participants
|
0.8176 Proportion of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48Population: As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)
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.
Outcome measures
| Measure |
Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 6-8
|
0.9412 Proportion of participants
|
0.9885 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 14-16
|
0.9176 Proportion of participants
|
0.9885 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 22-24
|
0.9059 Proportion of participants
|
0.9770 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 30-32
|
0.8824 Proportion of participants
|
0.9540 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 38-40
|
0.8585 Proportion of participants
|
0.8966 Proportion of participants
|
—
|
|
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Proportion by Week 46-48
|
0.8585 Proportion of participants
|
0.8823 Proportion of participants
|
—
|
SECONDARY outcome
Timeframe: End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance PhasePopulation: 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).
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.
Outcome measures
| Measure |
Switch Regimen
n=76 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=68 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
|
100 cells/mm3
Standard Error 14.7
|
92 cells/mm3
Standard Error 18.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24 of Induction PhasePopulation: Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).
Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.
Outcome measures
| Measure |
Switch Regimen
n=155 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=49 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
n=204 Participants
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
|
170 cells/mm3
Standard Error 10.0
|
201 cells/mm3
Standard Error 18.5
|
177 cells/mm3
Standard Error 8.8
|
SECONDARY outcome
Timeframe: Baseline, Week 48 of Rescue PhasePopulation: Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).
Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.
Outcome measures
| Measure |
Switch Regimen
n=38 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
|
313 cells/mm3
Standard Error 26.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24 of Induction PhasePopulation: Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).
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.
Outcome measures
| Measure |
Switch Regimen
n=151 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=47 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
n=198 Participants
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
|
-3.16 log10 c/mL
Standard Error 0.046
|
-3.35 log10 c/mL
Standard Error 0.135
|
-3.21 log10 c/mL
Standard Error 0.048
|
SECONDARY outcome
Timeframe: \Baseline, Week 48 of Rescue PhasePopulation: Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)
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.
Outcome measures
| Measure |
Switch Regimen
n=41 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
|
-3.71 log10 c/mL
Standard Error 0.078
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Switch Regimen
n=50 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Suppression Maintained Through Week 48
|
29 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Suppression, then Virologic Rebound at/before Wk48
|
7 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Discontinuation Before Week 48
|
8 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Viral Suppression Never Achieved
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 of Rescue PhaseTreatment 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.
Outcome measures
| Measure |
Switch Regimen
n=50 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Suppression Maintained Through Week 48
|
39 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Suppression, then Virologic Rebound at/before Wk48
|
2 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Discontinuation Before Week 48
|
9 Participants
|
—
|
—
|
|
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Viral Suppression Never Achieved
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16-18, Week 24-26, Week 38-40, Week 64-66Description: 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.
Outcome measures
| Measure |
Switch Regimen
n=172 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=80 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 16-18
|
131 Participants
|
3 Participants
|
—
|
|
Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 24-26
|
171 Participants
|
5 Participants
|
—
|
|
Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 38-40
|
172 Participants
|
31 Participants
|
—
|
|
Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 64-66
|
172 Participants
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16-18, Week 24-26, Week 30-32Time 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.
Outcome measures
| Measure |
Switch Regimen
n=172 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=80 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 24-26
|
171 Participants
|
54 Participants
|
—
|
|
Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
Number of Participants Suppressed by Week 16-18
|
168 Participants
|
39 Participants
|
—
|
|
Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
Number of Participants Suppressed by Wk 30-32
|
172 Participants
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: 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).Population: Participants who received at least 1 dose of Induction Phase study therapy.
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.
Outcome measures
| Measure |
Switch Regimen
n=172 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=80 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
n=252 Participants
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Summary of Adverse Events During Induction Phase
Deaths
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Summary of Adverse Events During Induction Phase
SAEs
|
7 Participants
|
9 Participants
|
16 Participants
|
|
Summary of Adverse Events During Induction Phase
SAEs related to study therapy
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Summary of Adverse Events During Induction Phase
AEs leading to discontinuation
|
0 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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).
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.
Outcome measures
| Measure |
Switch Regimen
n=87 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Summary of Adverse Events During Maintenance Phase
Deaths
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Adverse Events During Maintenance Phase
Serious Adverse Events (SAEs)
|
4 Participants
|
3 Participants
|
—
|
|
Summary of Adverse Events During Maintenance Phase
SAEs related to study therapy
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Adverse Events During Maintenance Phase
AEs leading to discontinuation
|
1 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Participants who received at least 1 dose of Rescue Phase study therapy
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.
Outcome measures
| Measure |
Switch Regimen
n=50 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Summary of Adverse Events During Rescue Phase
Deaths
|
1 Participants
|
—
|
—
|
|
Summary of Adverse Events During Rescue Phase
SAEs
|
2 Participants
|
—
|
—
|
|
Summary of Adverse Events During Rescue Phase
SAEs related to study therapy
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events During Rescue Phase
AEs leading to discontinuation
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.Population: 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.
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.
Outcome measures
| Measure |
Switch Regimen
n=81 Participants
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=77 Participants
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Total
All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
|
|---|---|---|---|
|
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
Total Cholesterol
|
-4.7 percent change
Interval -8.28 to -1.02
|
1.4 percent change
Interval -1.88 to 4.78
|
—
|
|
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
HDL Cholesterol
|
3.7 percent change
Interval -0.86 to 8.42
|
0.8 percent change
Interval -4.24 to 6.12
|
—
|
|
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
LDL Cholesterol
|
-0.7 percent change
Interval -6.7 to 5.8
|
-2.1 percent change
Interval -7.1 to 3.26
|
—
|
|
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
Triglycerides
|
-27.0 percent change
Interval -33.21 to -20.19
|
9.8 percent change
Interval -1.35 to 22.23
|
—
|
|
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
Non-HDL Cholesterol
|
-7.4 percent change
Interval -12.15 to -2.48
|
1.1 percent change
Interval -3.34 to 5.65
|
—
|
Adverse Events
Switch Regimen
Continuation Regimen
Non-Randomized Participants
Serious adverse events
| Measure |
Switch Regimen
n=87 participants at risk
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 participants at risk
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Non-Randomized Participants
n=80 participants at risk
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
|
|---|---|---|---|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
1.1%
1/87
|
0.00%
0/85
|
0.00%
0/80
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Gastrointestinal disorders
VOMITING
|
1.1%
1/87
|
0.00%
0/85
|
0.00%
0/80
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Gastrointestinal disorders
DUODENITIS
|
1.1%
1/87
|
0.00%
0/85
|
0.00%
0/80
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
1.1%
1/87
|
0.00%
0/85
|
0.00%
0/80
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
2.3%
2/87
|
0.00%
0/85
|
0.00%
0/80
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/87
|
0.00%
0/85
|
2.5%
2/80
|
|
Infections and infestations
PNEUMONIA
|
1.1%
1/87
|
1.2%
1/85
|
2.5%
2/80
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Infections and infestations
APPENDICEAL ABSCESS
|
0.00%
0/87
|
1.2%
1/85
|
0.00%
0/80
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECI PNEUMONIA
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/87
|
1.2%
1/85
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/87
|
1.2%
1/85
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/87
|
1.2%
1/85
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
1.1%
1/87
|
0.00%
0/85
|
0.00%
0/80
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.00%
0/87
|
0.00%
0/85
|
1.2%
1/80
|
Other adverse events
| Measure |
Switch Regimen
n=87 participants at risk
ATV 400 mg QD + 2 NRTIs
|
Continuation Regimen
n=85 participants at risk
ATV 300 mg + RTV 100 mg QD + 2 NRTIs
|
Non-Randomized Participants
n=80 participants at risk
All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
|
|---|---|---|---|
|
Eye disorders
OCULAR ICTERUS
|
17.2%
15/87
|
21.2%
18/85
|
7.5%
6/80
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
36.8%
32/87
|
38.8%
33/85
|
21.2%
17/80
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
9.2%
8/87
|
9.4%
8/85
|
8.8%
7/80
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
8.0%
7/87
|
3.5%
3/85
|
8.8%
7/80
|
|
Psychiatric disorders
DEPRESSION
|
5.7%
5/87
|
2.4%
2/85
|
3.8%
3/80
|
|
Hepatobiliary disorders
JAUNDICE
|
4.6%
4/87
|
10.6%
9/85
|
3.8%
3/80
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
5.7%
5/87
|
5.9%
5/85
|
6.2%
5/80
|
|
Nervous system disorders
HEADACHE
|
12.6%
11/87
|
15.3%
13/85
|
10.0%
8/80
|
|
Gastrointestinal disorders
NAUSEA
|
11.5%
10/87
|
15.3%
13/85
|
15.0%
12/80
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
2/87
|
5.9%
5/85
|
6.2%
5/80
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.1%
14/87
|
16.5%
14/85
|
6.2%
5/80
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.0%
7/87
|
10.6%
9/85
|
2.5%
2/80
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.1%
1/87
|
5.9%
5/85
|
5.0%
4/80
|
|
Infections and infestations
SINUSITIS
|
2.3%
2/87
|
5.9%
5/85
|
0.00%
0/80
|
|
Infections and infestations
BRONCHITIS
|
9.2%
8/87
|
8.2%
7/85
|
2.5%
2/80
|
|
Infections and infestations
PHARYNGITIS
|
6.9%
6/87
|
1.2%
1/85
|
1.2%
1/80
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.7%
5/87
|
8.2%
7/85
|
8.8%
7/80
|
|
Infections and infestations
VIRAL INFECTION
|
3.4%
3/87
|
2.4%
2/85
|
6.2%
5/80
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.3%
2/87
|
1.2%
1/85
|
5.0%
4/80
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
2.3%
2/87
|
1.2%
1/85
|
5.0%
4/80
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.4%
3/87
|
8.2%
7/85
|
5.0%
4/80
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.6%
4/87
|
7.1%
6/85
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
3.4%
3/87
|
7.1%
6/85
|
6.2%
5/80
|
|
General disorders
PYREXIA
|
5.7%
5/87
|
5.9%
5/85
|
1.2%
1/80
|
|
General disorders
ASTHENIA
|
8.0%
7/87
|
11.8%
10/85
|
10.0%
8/80
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
3.4%
3/87
|
7.1%
6/85
|
3.8%
3/80
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER