Trial Outcomes & Findings for Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients (NCT NCT00819052)
NCT ID: NCT00819052
Last Updated: 2014-11-10
Results Overview
Primary endpoint was the number of patients with a sustained virologic response through week 24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
445 participants
Primary outcome timeframe
week 24
Results posted on
2014-11-10
Participant Flow
Two patients were randomized, but have not been treated. They were excluded from the treated set.
Participant milestones
| Measure |
Nevirapine Immediate Release (NVP IR)
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
Nevirapine extended release 400 mg tablets given once daily
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
295
|
|
Overall Study
COMPLETED
|
142
|
281
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
| Measure |
Nevirapine Immediate Release (NVP IR)
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
Nevirapine extended release 400 mg tablets given once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Death or events leading to death
|
1
|
0
|
Baseline Characteristics
Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
Baseline characteristics by cohort
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Age, Customized
18 to < 41 years
|
36 participants
n=5 Participants
|
70 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Age, Customized
41 to < 56 years
|
79 participants
n=5 Participants
|
168 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Age, Customized
56 to < 65 years
|
24 participants
n=5 Participants
|
38 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age, Customized
65 years or more
|
9 participants
n=5 Participants
|
19 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=5 Participants
|
20 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
134 participants
n=5 Participants
|
270 participants
n=7 Participants
|
404 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
132 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic / Latino
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
46 participants
n=5 Participants
|
98 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
102 participants
n=5 Participants
|
197 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Smoking History
Never smoked
|
68 participants
n=5 Participants
|
131 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Smoking History
Ex-smoker
|
37 participants
n=5 Participants
|
67 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Smoking History
Current smoker
|
43 participants
n=5 Participants
|
97 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Alcohol Status
Non drinker
|
44 participants
n=5 Participants
|
75 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Alcohol Status
Drinks - no interfere with trial
|
103 participants
n=5 Participants
|
214 participants
n=7 Participants
|
317 participants
n=5 Participants
|
|
Alcohol Status
Drinks - could interfere with trial
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 24Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Primary endpoint was the number of patients with a sustained virologic response through week 24
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
137 participants
|
276 participants
|
—
|
|
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
11 participants
|
19 participants
|
—
|
SECONDARY outcome
Timeframe: week 2Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Endpoint was the number of patients with a sustained virologic response through week 2
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Responder
|
148 participants
|
292 participants
|
—
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Non responder
|
0 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: week 4Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Endpoint was the number of patients with a sustained virologic response through week 4
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Responder
|
146 participants
|
291 participants
|
—
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Non responder
|
2 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: week 8Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Endpoint was the number of patients with a sustained virologic response through week 8
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Responder
|
146 participants
|
290 participants
|
—
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Non responder
|
2 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Endpoint was the number of patients with a sustained virologic response through week 12
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Responder
|
143 participants
|
289 participants
|
—
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Non responder
|
5 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: week 24Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Endpoint was the number of patients with a sustained virologic response through week 24
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Responder
|
140 participants
|
285 participants
|
—
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Non responder
|
8 participants
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: week 0 to 24Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 0 to <2
|
1 proportion of participants
|
1 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 2 to <4
|
1 proportion of participants
|
0.986 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 4 to <8
|
0.993 proportion of participants
|
0.98 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 8 to <12
|
0.973 proportion of participants
|
0.973 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 12 to <16
|
0.959 proportion of participants
|
0.966 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 16 to <20
|
0.946 proportion of participants
|
0.953 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 20 to <24
|
0.946 proportion of participants
|
0.946 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 24 to <28
|
0.946 proportion of participants
|
0.942 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: week 0Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=147 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
|
569.7 cells/cubic millimeter
Standard Deviation 215.6
|
557.7 cells/cubic millimeter
Standard Deviation 213.2
|
—
|
SECONDARY outcome
Timeframe: baseline, week 2Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=141 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=280 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
|
3.7 cells/cubic millimeter
Standard Deviation 115.2
|
-4.7 cells/cubic millimeter
Standard Deviation 107.7
|
—
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=137 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=271 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
|
0.8 cells/cubic millimeter
Standard Deviation 110.8
|
-15.4 cells/cubic millimeter
Standard Deviation 114.1
|
—
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=139 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=281 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
|
-18.6 cells/cubic millimeter
Standard Deviation 122.9
|
-24.4 cells/cubic millimeter
Standard Deviation 117.6
|
—
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=139 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=283 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
|
22.3 cells/cubic millimeter
Standard Deviation 152.9
|
-10.2 cells/cubic millimeter
Standard Deviation 118.5
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=142 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=282 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
|
50.4 cells/cubic millimeter
Standard Deviation 162.8
|
45.7 cells/cubic millimeter
Standard Deviation 137.6
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=142 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=282 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
|
50.74 cells/cubic millimeter
Standard Error 12.7072
|
46.10 cells/cubic millimeter
Standard Error 9.2053
|
—
|
SECONDARY outcome
Timeframe: week 48Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.
Endpoint was the number of patients with a sustained virologic response through week 48
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=130 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=12 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=276 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
125 participants
|
11 participants
|
268 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
5 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: week 60Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.
Endpoint was the number of patients with a sustained virologic response through week 60
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=130 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=12 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=274 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
122 participants
|
9 participants
|
253 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
8 participants
|
3 participants
|
21 participants
|
SECONDARY outcome
Timeframe: week 72Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.
Endpoint was the number of patients with a sustained virologic response through week 72
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=130 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=9 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=271 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
124 participants
|
9 participants
|
265 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
6 participants
|
0 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 84Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.
Endpoint was the number of patients with a sustained virologic response through week 84
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=125 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=268 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
118 participants
|
7 participants
|
244 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
7 participants
|
1 participants
|
24 participants
|
SECONDARY outcome
Timeframe: week 96Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.
Endpoint was the number of patients with a sustained virologic response through week 96
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=124 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=9 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=263 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
117 participants
|
9 participants
|
242 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
7 participants
|
0 participants
|
21 participants
|
SECONDARY outcome
Timeframe: week 108Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.
Endpoint was the number of patients with a sustained virologic response through week 108
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=125 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=9 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=260 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
119 participants
|
8 participants
|
247 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
6 participants
|
1 participants
|
13 participants
|
SECONDARY outcome
Timeframe: week 120Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.
Endpoint was the number of patients with a sustained virologic response through week 120
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=121 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=258 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
112 participants
|
7 participants
|
235 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
9 participants
|
1 participants
|
23 participants
|
SECONDARY outcome
Timeframe: week 132Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.
Endpoint was the number of patients with a sustained virologic response through week 132
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=121 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=7 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=252 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
115 participants
|
6 participants
|
238 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
6 participants
|
1 participants
|
14 participants
|
SECONDARY outcome
Timeframe: week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.
Endpoint was the number of patients with a sustained virologic response through week 144
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=121 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=7 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=250 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
115 participants
|
7 participants
|
238 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
6 participants
|
0 participants
|
12 participants
|
SECONDARY outcome
Timeframe: last available visit, up to 144 weeksPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).
Endpoint was the number of patients with a sustained virologic response at their last available visit
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=130 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=13 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=276 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
121 participants
|
11 participants
|
261 participants
|
|
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
9 participants
|
2 participants
|
15 participants
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=126 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=11 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=267 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
|
77.8 cells/cubic millimeter
Standard Deviation 142.8
|
139.8 cells/cubic millimeter
Standard Deviation 126.9
|
52.7 cells/cubic millimeter
Standard Deviation 143.5
|
SECONDARY outcome
Timeframe: baseline, week 60Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=126 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=12 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=273 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
|
51.1 cells/cubic millimeter
Standard Deviation 138.1
|
11.5 cells/cubic millimeter
Standard Deviation 138.4
|
55.1 cells/cubic millimeter
Standard Deviation 136.5
|
SECONDARY outcome
Timeframe: baseline, week 72Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=126 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=9 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=265 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
|
61.3 cells/cubic millimeter
Standard Deviation 128.6
|
77.9 cells/cubic millimeter
Standard Deviation 109.5
|
67.4 cells/cubic millimeter
Standard Deviation 141.5
|
SECONDARY outcome
Timeframe: baseline, week 84Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=123 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=265 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
|
80.3 cells/cubic millimeter
Standard Deviation 156.5
|
134.6 cells/cubic millimeter
Standard Deviation 214.2
|
55.0 cells/cubic millimeter
Standard Deviation 130.9
|
SECONDARY outcome
Timeframe: baseline, week 96Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=120 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=239 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
|
55.1 cells/cubic millimeter
Standard Deviation 156.7
|
55.4 cells/cubic millimeter
Standard Deviation 80.7
|
60.2 cells/cubic millimeter
Standard Deviation 130.3
|
SECONDARY outcome
Timeframe: baseline, week 108Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=124 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=256 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
|
72.4 cells/cubic millimeter
Standard Deviation 160.4
|
117.4 cells/cubic millimeter
Standard Deviation 151.3
|
73.5 cells/cubic millimeter
Standard Deviation 151.0
|
SECONDARY outcome
Timeframe: baseline, week 120Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=119 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=8 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=258 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
|
79.5 cells/cubic millimeter
Standard Deviation 168.4
|
90.0 cells/cubic millimeter
Standard Deviation 151.0
|
66.6 cells/cubic millimeter
Standard Deviation 182.3
|
SECONDARY outcome
Timeframe: baseline, week 132Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=120 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=7 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=252 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
|
58.8 cells/cubic millimeter
Standard Deviation 153.6
|
124.8 cells/cubic millimeter
Standard Deviation 158.7
|
70.8 cells/cubic millimeter
Standard Deviation 146.7
|
SECONDARY outcome
Timeframe: baseline, week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=120 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=7 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=250 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
|
85.3 cells/cubic millimeter
Standard Deviation 151.6
|
205.6 cells/cubic millimeter
Standard Deviation 388.6
|
82.7 cells/cubic millimeter
Standard Deviation 157.4
|
SECONDARY outcome
Timeframe: baseline, last available visit (up to 144 weeks)Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=129 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=13 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=276 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population
|
71.9 cells/cubic millimeter
Standard Deviation 157.1
|
165.9 cells/cubic millimeter
Standard Deviation 302.5
|
80.9 cells/cubic millimeter
Standard Deviation 163.5
|
SECONDARY outcome
Timeframe: week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.
Endpoint was the number of patients with a sustained virologic response through week 144
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=121 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=7 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=250 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
Responder
|
121 participants
|
7 participants
|
250 participants
|
|
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
No Responder
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visitPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=130 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=13 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
n=276 Participants
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 48 (N=130, 12, 275)
|
48.4 copies/mL
Standard Deviation 536.9
|
58.4 copies/mL
Standard Deviation 202.3
|
-4.3 copies/mL
Standard Deviation 67.6
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 60 (N=130, 12, 274)
|
11004.4 copies/mL
Standard Deviation 125415
|
94.1 copies/mL
Standard Deviation 218.5
|
-1.8 copies/mL
Standard Deviation 69.4
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 72 (N=129, 9, 271)
|
1747.0 copies/mL
Standard Deviation 19806
|
0.0 copies/mL
Standard Deviation 0.0
|
-4.9 copies/mL
Standard Deviation 68.2
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 84 (N=125, 8, 268)
|
2798.8 copies/mL
Standard Deviation 31301
|
4.1 copies/mL
Standard Deviation 11.7
|
4140.1 copies/mL
Standard Deviation 67801
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 96 (N=124, 9, 263)
|
0.2 copies/mL
Standard Deviation 17.7
|
0.0 copies/mL
Standard Deviation 0.0
|
168.4 copies/mL
Standard Deviation 1974.7
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 108 (N=125, 8, 260)
|
53.1 copies/mL
Standard Deviation 574.2
|
0.0 copies/mL
Standard Deviation 0.0
|
-3.5 copies/mL
Standard Deviation 70.6
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 120 (N=121, 8, 257)
|
3.5 copies/mL
Standard Deviation 42.7
|
0.4 copies/mL
Standard Deviation 1.1
|
-2.3 copies/mL
Standard Deviation 71.0
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 132 (121, 7, 252)
|
10.2 copies/mL
Standard Deviation 78.7
|
4.0 copies/mL
Standard Deviation 10.6
|
-1.8 copies/mL
Standard Deviation 79.0
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
week 144 (N=121, 7, 250)
|
1.0 copies/mL
Standard Deviation 24.5
|
0.0 copies/mL
Standard Deviation 0.0
|
-4.6 copies/mL
Standard Deviation 70.9
|
|
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
last available visit(N=130,13,276)
|
4472.6 copies/mL
Standard Deviation 36357
|
86.4 copies/mL
Standard Deviation 211.0
|
4103.2 copies/mL
Standard Deviation 66822
|
SECONDARY outcome
Timeframe: until week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
Occurence of investigations related to treatment
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Changes in Safety Parameters Related to Treatment
Alanine aminotransferase increased
|
1 participants
|
4 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Aspartate aminotransferase increased
|
0 participants
|
2 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Blood amylase increased
|
1 participants
|
0 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Blood triglycerides increased
|
1 participants
|
0 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Gamma-glutamyltransferase increased
|
0 participants
|
2 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Lipase increased
|
1 participants
|
0 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Liver function test abnormal
|
1 participants
|
0 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Blood glucose increased
|
0 participants
|
1 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Blood lacate dehydrogenase increased
|
0 participants
|
1 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Neutrophil count decreased
|
0 participants
|
1 participants
|
—
|
|
Changes in Safety Parameters Related to Treatment
Transaminases increased
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 144 weeksPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
drug-related rashes by severity
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Occurence of Rashes
rash Grade 1 mild
|
0 participants
|
1 participants
|
—
|
|
Occurence of Rashes
rash Grade 2 moderate
|
0 participants
|
1 participants
|
—
|
|
Occurence of Rashes
rash Grade 3 severe
|
0 participants
|
0 participants
|
—
|
|
Occurence of Rashes
rash Grade 4 potential life-threatening
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 144 weeksPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Occurence of Hepatic Events
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 144 weeksPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
New AIDS or AIDS-related Progression Event or Death
new AIDS or AIDS related progression
|
1 participants
|
2 participants
|
—
|
|
New AIDS or AIDS-related Progression Event or Death
death
|
2 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Time to Loss of Virologic Response
|
393 days
Interval 393.0 to 406.0
|
391 days
Interval 377.0 to 423.0
|
—
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: All patients in the treated set who experienced virologic failure.
Genotypic resistance associated with virologic failure. This endpoint was not analysed due to lack of data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to week 48Population: All patients with evaluable PK data.
Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).
Outcome measures
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Nevirapine XR After Week 48
Patient remained on NVP XR after week 48
|
|---|---|---|---|
|
Trough Plasma Concentration
Day 1 (N=146, 0)
|
3720 ng/mL
Geometric Coefficient of Variation 65.4
|
NA ng/mL
Geometric Coefficient of Variation NA
No data was available at this time point
|
—
|
|
Trough Plasma Concentration
Week 2 (N=107, 229)
|
3650 ng/mL
Geometric Coefficient of Variation 38.1
|
3270 ng/mL
Geometric Coefficient of Variation 57.6
|
—
|
|
Trough Plasma Concentration
Week 4 (N=103, 234)
|
3720 ng/mL
Geometric Coefficient of Variation 36.6
|
3230 ng/mL
Geometric Coefficient of Variation 49.0
|
—
|
|
Trough Plasma Concentration
Week 8 (N=110, 225)
|
4080 ng/mL
Geometric Coefficient of Variation 38.2
|
3650 ng/mL
Geometric Coefficient of Variation 46.1
|
—
|
|
Trough Plasma Concentration
Week 12 (N=103, 223)
|
4170 ng/mL
Geometric Coefficient of Variation 41.1
|
3590 ng/mL
Geometric Coefficient of Variation 50.2
|
—
|
|
Trough Plasma Concentration
Week 24 (N=103, 212)
|
4080 ng/mL
Geometric Coefficient of Variation 36.9
|
3750 ng/mL
Geometric Coefficient of Variation 41.8
|
—
|
|
Trough Plasma Concentration
Week 36 (N=103, 215)
|
4370 ng/mL
Geometric Coefficient of Variation 40.6
|
3930 ng/mL
Geometric Coefficient of Variation 41.5
|
—
|
|
Trough Plasma Concentration
Week 48 (N=101, 213)
|
3960 ng/mL
Geometric Coefficient of Variation 41.8
|
3650 ng/mL
Geometric Coefficient of Variation 45.0
|
—
|
Adverse Events
Nevirapine Immediate Release (NVP IR)
Serious events: 33 serious events
Other events: 110 other events
Deaths: 0 deaths
Nevirapine Extended Release (NVP XR)
Serious events: 73 serious events
Other events: 244 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 participants at risk
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 participants at risk
Nevirapine extended release 400 mg tablets given once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/148 • 144 weeks
|
1.0%
3/295 • 144 weeks
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Cardiac disorders
Tachyarrhythmia
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.68%
1/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.68%
1/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.68%
1/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Adverse drug reaction
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Chest pain
|
1.4%
2/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Dysplasia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Hernia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Inflammation
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Infections and infestations
Abscess neck
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Anal abscess
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Appendicitis
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Bronchitis
|
0.68%
1/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Infections and infestations
Endocarditis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Erysipelas
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Herpes zoster
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Infections and infestations
Intervertebral discitis
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Meningitis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Pneumonia
|
1.4%
2/148 • 144 weeks
|
1.0%
3/295 • 144 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Shigella infection
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Syphilis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.68%
1/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.7%
4/148 • 144 weeks
|
1.0%
3/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Nervous system disorders
Brain stem ischaemia
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Nervous system disorders
Headache
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Psychiatric disorders
Depression
|
2.0%
3/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.68%
1/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/148 • 144 weeks
|
0.34%
1/295 • 144 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.68%
1/148 • 144 weeks
|
0.00%
0/295 • 144 weeks
|
|
Vascular disorders
Varicose vein
|
0.00%
0/148 • 144 weeks
|
0.68%
2/295 • 144 weeks
|
Other adverse events
| Measure |
Nevirapine Immediate Release (NVP IR)
n=148 participants at risk
Nevirapine immediate release 200 mg tablets given twice daily
|
Nevirapine Extended Release (NVP XR)
n=295 participants at risk
Nevirapine extended release 400 mg tablets given once daily
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
5.4%
8/148 • 144 weeks
|
3.7%
11/295 • 144 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
20/148 • 144 weeks
|
21.0%
62/295 • 144 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
2/148 • 144 weeks
|
5.4%
16/295 • 144 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.7%
4/148 • 144 weeks
|
6.8%
20/295 • 144 weeks
|
|
General disorders
Fatigue
|
6.1%
9/148 • 144 weeks
|
10.2%
30/295 • 144 weeks
|
|
Infections and infestations
Bronchitis
|
16.2%
24/148 • 144 weeks
|
16.6%
49/295 • 144 weeks
|
|
Infections and infestations
Gastroenteritis
|
8.1%
12/148 • 144 weeks
|
5.4%
16/295 • 144 weeks
|
|
Infections and infestations
Herpes zoster
|
2.0%
3/148 • 144 weeks
|
5.1%
15/295 • 144 weeks
|
|
Infections and infestations
Nasopharyngitis
|
16.9%
25/148 • 144 weeks
|
25.1%
74/295 • 144 weeks
|
|
Infections and infestations
Pharyngitis
|
6.8%
10/148 • 144 weeks
|
5.4%
16/295 • 144 weeks
|
|
Infections and infestations
Sinusitis
|
13.5%
20/148 • 144 weeks
|
11.2%
33/295 • 144 weeks
|
|
Infections and infestations
Syphilis
|
4.7%
7/148 • 144 weeks
|
8.1%
24/295 • 144 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.2%
21/148 • 144 weeks
|
11.9%
35/295 • 144 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.7%
7/148 • 144 weeks
|
6.4%
19/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
13/148 • 144 weeks
|
6.8%
20/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
20/148 • 144 weeks
|
13.6%
40/295 • 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
2/148 • 144 weeks
|
5.4%
16/295 • 144 weeks
|
|
Nervous system disorders
Headache
|
8.8%
13/148 • 144 weeks
|
10.5%
31/295 • 144 weeks
|
|
Psychiatric disorders
Depression
|
6.8%
10/148 • 144 weeks
|
11.2%
33/295 • 144 weeks
|
|
Psychiatric disorders
Insomnia
|
6.1%
9/148 • 144 weeks
|
7.5%
22/295 • 144 weeks
|
|
Psychiatric disorders
Sleep disorder
|
2.7%
4/148 • 144 weeks
|
5.1%
15/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
18/148 • 144 weeks
|
12.2%
36/295 • 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
3/148 • 144 weeks
|
5.4%
16/295 • 144 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.68%
1/148 • 144 weeks
|
6.1%
18/295 • 144 weeks
|
|
Vascular disorders
Hypertension
|
10.1%
15/148 • 144 weeks
|
9.5%
28/295 • 144 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER