Trial Outcomes & Findings for Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients (NCT NCT00543803)
NCT ID: NCT00543803
Last Updated: 2014-05-20
Results Overview
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Recruitment status
COMPLETED
Target enrollment
334 participants
Primary outcome timeframe
from baseline to last value on treatment in between 36 months
Results posted on
2014-05-20
Participant Flow
Participant milestones
| Measure |
Patients Treated With Viramune in Combination With Truvada
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
|---|---|
|
Overall Study
STARTED
|
334
|
|
Overall Study
COMPLETED
|
192
|
|
Overall Study
NOT COMPLETED
|
142
|
Reasons for withdrawal
| Measure |
Patients Treated With Viramune in Combination With Truvada
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Other
|
86
|
Baseline Characteristics
Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
Baseline characteristics by cohort
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=334 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=295 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
|
1.0 IU/L
Interval -3.0 to 7.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=317 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
|
4.0 IU/L
Interval -4.0 to 15.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=315 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
|
23.0 IU/L
Interval 9.0 to 59.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in Creatinine from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=312 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Creatinine to Last Value on Treatment
|
0.0 mg/dl
Interval -0.1 to 0.1
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in total cholesterol from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=262 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
|
12.0 mg/dl
Interval -12.0 to 40.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=214 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
|
6.0 mg/dl
Interval -1.0 to 15.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=208 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
|
5.0 mg/dl
Interval -15.0 to 27.5
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in triglycerides from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=267 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Triglycerides to Last Value on Treatment
|
-7.0 mg/dl
Interval -54.0 to 29.0
|
—
|
PRIMARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
The change in Glucose from baseline to the last value in treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=276 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in Glucose to Last Value on Treatment
|
0.0 mg/dl
Interval -8.0 to 8.5
|
—
|
SECONDARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
For calculation of this measure switch patients are included in the total which had no viral load decrease.
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=311 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
|
-2.3 (log10 copies) / ml
Interval -4.53 to 0.0
|
—
|
SECONDARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=312 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
|
141 (cells) / mm^3
Interval 30.5 to 276.5
|
—
|
SECONDARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
Total number of patients with investigator defined non-serious drug-related AEs was reported.
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=334 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
|
57 participants
|
—
|
SECONDARY outcome
Timeframe: from baseline to last value on treatment in between 36 monthsPopulation: FAS- All patients were considered for the full analysis set.
Investigators opinion of patients general health condition at baseline versus last evaluation on treatment
Outcome measures
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=334 Participants
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
|
Last Evaluation Assessment on Treatment
n=334 Participants
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
|
|---|---|---|
|
Investigator's Global Clinical Assessment of Patient General Health Status
Good
|
193 participants
|
273 participants
|
|
Investigator's Global Clinical Assessment of Patient General Health Status
Moderate
|
127 participants
|
49 participants
|
|
Investigator's Global Clinical Assessment of Patient General Health Status
Bad
|
10 participants
|
4 participants
|
|
Investigator's Global Clinical Assessment of Patient General Health Status
Missing
|
4 participants
|
8 participants
|
Adverse Events
Patients Treated With Viramune in Combination With Truvada
Serious events: 19 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=334 participants at risk
Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/334 • 36 months
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.30%
1/334 • 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/334 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.30%
1/334 • 36 months
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.30%
1/334 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/334 • 36 months
|
|
General disorders
Condition aggravated
|
0.30%
1/334 • 36 months
|
|
General disorders
Disease recurrence
|
0.30%
1/334 • 36 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/334 • 36 months
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.30%
1/334 • 36 months
|
|
Hepatobiliary disorders
Jaundice
|
0.30%
1/334 • 36 months
|
|
Infections and infestations
Anogenital warts
|
0.30%
1/334 • 36 months
|
|
Infections and infestations
Meningitis
|
0.30%
1/334 • 36 months
|
|
Infections and infestations
Pilonidal cyst
|
0.30%
1/334 • 36 months
|
|
Infections and infestations
Pneumonia
|
0.30%
1/334 • 36 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.30%
1/334 • 36 months
|
|
Injury, poisoning and procedural complications
Face injury
|
0.30%
1/334 • 36 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.30%
1/334 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/334 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.30%
1/334 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.30%
1/334 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.30%
1/334 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/334 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.30%
1/334 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligodendroglioma
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Cerebellar ataxia
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Dizziness
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Epilepsy
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Nervous system disorder
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Neuromyopathy
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Nystagmus
|
0.30%
1/334 • 36 months
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.30%
1/334 • 36 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.30%
1/334 • 36 months
|
|
Psychiatric disorders
Drug abuse
|
0.30%
1/334 • 36 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.30%
1/334 • 36 months
|
|
Surgical and medical procedures
Debridement
|
0.30%
1/334 • 36 months
|
Other adverse events
| Measure |
Patients Treated With Viramune in Combination With Truvada
n=334 participants at risk
Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
19/334 • 36 months
|
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