Trial Outcomes & Findings for Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice (NCT NCT01524900)
NCT ID: NCT01524900
Last Updated: 2015-06-02
Results Overview
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
Recruitment status
COMPLETED
Target enrollment
398 participants
Primary outcome timeframe
up to 72 weeks
Results posted on
2015-06-02
Participant Flow
387 patients started treatment.
Participant milestones
| Measure |
Treatment-naive Patients
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
246
|
30
|
22
|
40
|
|
Overall Study
COMPLETED
|
43
|
232
|
29
|
21
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment-naive Patients
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
12
|
1
|
0
|
0
|
|
Overall Study
Other reason than stated above
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
No reason documented
|
2
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
Baseline characteristics by cohort
| Measure |
Treatment-naive Patients
n=49 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=246 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=30 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load>50 Copies/mL
n=22 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=40 Participants
Patients with no documented information about the baseline viral load.
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
37.4 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
38.5 years
STANDARD_DEVIATION 13.1 • n=10 Participants
|
|
Gender
Female
|
8 participants
n=5 Participants
|
90 participants
n=7 Participants
|
11 participants
n=5 Participants
|
7 participants
n=4 Participants
|
19 participants
n=21 Participants
|
135 participants
n=10 Participants
|
|
Gender
Male
|
41 participants
n=5 Participants
|
155 participants
n=7 Participants
|
19 participants
n=5 Participants
|
14 participants
n=4 Participants
|
21 participants
n=21 Participants
|
250 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 72 weeksPopulation: Patients from TS.
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
Outcome measures
| Measure |
Treatment-naive Patients
n=49 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=246 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=30 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=22 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=40 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
Patients with SAEs leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
Patients with nSAEs leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
Patients reporting non-serious adverse events
|
0 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
Patients with serious adverse events
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: up to 72 weeksPopulation: Patients TS
Number of patients reporting rash of any severity as adverse event
Outcome measures
| Measure |
Treatment-naive Patients
n=49 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=246 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=30 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=22 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=40 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Number of Patients Reporting Rash of Any Severity
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: up to 72 weeksNumber of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.
Outcome measures
| Measure |
Treatment-naive Patients
n=49 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=246 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=30 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=22 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=40 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Number of Patients Reporting Hepatic Events
Abnormality in ALT
|
11 participants
|
22 participants
|
7 participants
|
9 participants
|
8 participants
|
|
Number of Patients Reporting Hepatic Events
Abnormality in Gamma-GT
|
11 participants
|
64 participants
|
7 participants
|
5 participants
|
4 participants
|
|
Number of Patients Reporting Hepatic Events
Hepatic events reported as AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reporting Hepatic Events
Abnormality in AST
|
1 participants
|
3 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Patients Reporting Hepatic Events
Abnormality in Bilirubin
|
4 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.
Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of \< 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.
Outcome measures
| Measure |
Treatment-naive Patients
n=40 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=223 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=29 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=21 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=37 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
Virologic response
|
21 participants
|
150 participants
|
15 participants
|
3 participants
|
11 participants
|
|
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
No virologic response
|
3 participants
|
10 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
Missing
|
16 participants
|
63 participants
|
13 participants
|
16 participants
|
25 participants
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Patients from FAS with documented CD4+ at baseline and after 24 weeks.
The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.
Outcome measures
| Measure |
Treatment-naive Patients
n=23 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=156 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=22 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=13 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=27 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 24
|
19.6 cells/mm^3
Standard Deviation 347.8
|
98.9 cells/mm^3
Standard Deviation 199.7
|
73.5 cells/mm^3
Standard Deviation 152.2
|
31.2 cells/mm^3
Standard Deviation 148.4
|
135.9 cells/mm^3
Standard Deviation 583.5
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.
The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
Outcome measures
| Measure |
Treatment-naive Patients
n=17 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=205 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=28 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=21 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=33 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks
|
0.3 units on a scale
Standard Deviation 1.1
|
0.4 units on a scale
Standard Deviation 1.2
|
0.7 units on a scale
Standard Deviation 1.2
|
0.8 units on a scale
Standard Deviation 2.1
|
-0.1 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Patients from FAS
The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.
Outcome measures
| Measure |
Treatment-naive Patients
n=40 Participants
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=223 Participants
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=29 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load >50 Copies/mL
n=21 Participants
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=37 Participants
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
Once daily intake is more convenient
|
4 participants
|
41 participants
|
6 participants
|
4 participants
|
7 participants
|
|
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
Once daily intake is very much more convenient
|
29 participants
|
105 participants
|
17 participants
|
14 participants
|
26 participants
|
Adverse Events
Treatment-naïve Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Switching From Nevirapine IR
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load > 50 Copies/ML
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Baseline Viral Load Not Documented
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-naïve Patients
n=49 participants at risk
Patients who were not pretreated with HIV therapy
|
Patients Switching From Nevirapine IR
n=246 participants at risk
Patients switching from nevirapine immediate release (IR).
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML
n=30 participants at risk
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/ML
n=22 participants at risk
Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=40 participants at risk
Patients with no documented information about the baseline viral load.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disorder
|
0.00%
0/49 • Up to 72 weeks
|
0.41%
1/246 • Up to 72 weeks
|
0.00%
0/30 • Up to 72 weeks
|
0.00%
0/22 • Up to 72 weeks
|
0.00%
0/40 • Up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49 • Up to 72 weeks
|
0.41%
1/246 • Up to 72 weeks
|
0.00%
0/30 • Up to 72 weeks
|
0.00%
0/22 • Up to 72 weeks
|
0.00%
0/40 • Up to 72 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/49 • Up to 72 weeks
|
0.41%
1/246 • Up to 72 weeks
|
0.00%
0/30 • Up to 72 weeks
|
0.00%
0/22 • Up to 72 weeks
|
0.00%
0/40 • Up to 72 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER