Trial Outcomes & Findings for PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice. (NCT NCT00736502)

NCT ID: NCT00736502

Last Updated: 2014-03-07

Results Overview

the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.

• Recruitment status: COMPLETED
• Target enrollment: 280 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2014-03-07

Participant Flow

There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.

This was an observational, non-interventional, uncontrolled, prospective post marketing study.

Participant milestones

Measure	Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Study STARTED	278
Overall Study COMPLETED	213
Overall Study NOT COMPLETED	65

Reasons for withdrawal

Measure	Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Study Adverse Event	22
Overall Study Lack of Efficacy	16
Overall Study Lost to Follow-up	27

Baseline Characteristics

PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

Baseline characteristics by cohort

Measure	Nevirapine n=278 Participants Patients treated with 200 mg Nevirapine twice daily (administered orally).
Age, Continuous	38.5 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	219 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.

the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.

Outcome measures

Measure	Nevirapine n=278 Participants Patients treated with 200 mg Nevirapine twice daily (administered orally).
Proportion of Patients Reporting Adverse Events any event	25.5 Percentage of participants
Proportion of Patients Reporting Adverse Events serious adverse events	4.3 Percentage of participants
Proportion of Patients Reporting Adverse Events adverse events leading to discontinuation	9.7 Percentage of participants
Proportion of Patients Reporting Adverse Events rash, any severity	3.2 Percentage of participants
Proportion of Patients Reporting Adverse Events hepatic events, any severity	3.2 Percentage of participants
Proportion of Patients Reporting Adverse Events Central Nervous system side effects, any severity	3.6 Percentage of participants

SECONDARY outcome

Timeframe: 48 weeks

Population: TS

VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by 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 was defined as a permanent discontinuation of Nevirapine.

Outcome measures

Measure	Nevirapine n=278 Participants Patients treated with 200 mg Nevirapine twice daily (administered orally).
Virologic Response (VR) with VR	139 Participants
Virologic Response (VR) without VR	16 Participants
Virologic Response (VR) missing	123 Participants

SECONDARY outcome

Timeframe: Baseline and week 48

Population: TS with non-missing data at baseline and week 48

Calculated as CD4+ cell count at week 48 minus the baseline value

Outcome measures

Measure	Nevirapine n=155 Participants Patients treated with 200 mg Nevirapine twice daily (administered orally).
Change in CD4+ Cell Count From Baseline to Week 48	148.5 Cells/mm^3 Standard Deviation 154.6

Adverse Events

Nevirapine

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nevirapine n=278 participants at risk Patients treated with 200 mg Nevirapine twice daily (administered orally).
Blood and lymphatic system disorders Anemia	0.36% 1/278 • 48 weeks
Blood and lymphatic system disorders Lymphadenopathy, generalised	0.36% 1/278 • 48 weeks
Blood and lymphatic system disorders Pancytopenia	0.36% 1/278 • 48 weeks
Gastrointestinal disorders Abdominal pain	0.36% 1/278 • 48 weeks
Gastrointestinal disorders Cholecystitis	0.36% 1/278 • 48 weeks
Gastrointestinal disorders Diarrhea	0.36% 1/278 • 48 weeks
Gastrointestinal disorders Gastroenteritis	0.36% 1/278 • 48 weeks
Gastrointestinal disorders Melena	0.36% 1/278 • 48 weeks
General disorders Fever	0.72% 2/278 • 48 weeks
General disorders Malaise	0.36% 1/278 • 48 weeks
General disorders Pregnancy	0.36% 1/278 • 48 weeks
Infections and infestations Clostridia enteritis	0.36% 1/278 • 48 weeks
Infections and infestations Helicobacter phylori infection	0.36% 1/278 • 48 weeks
Infections and infestations porta catheter infection	0.36% 1/278 • 48 weeks
Infections and infestations Staphylococcus sepsis	0.36% 1/278 • 48 weeks
Injury, poisoning and procedural complications Fracture of foot	0.36% 1/278 • 48 weeks
Investigations Hyperkaliemia	0.36% 1/278 • 48 weeks
Musculoskeletal and connective tissue disorders Chest pain	0.36% 1/278 • 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma of the brain	0.36% 1/278 • 48 weeks
Nervous system disorders Diabetes insipitus	0.36% 1/278 • 48 weeks
Respiratory, thoracic and mediastinal disorders Pneumocystitis	0.36% 1/278 • 48 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	0.72% 2/278 • 48 weeks
Skin and subcutaneous tissue disorders Enanthema	0.36% 1/278 • 48 weeks
Skin and subcutaneous tissue disorders Herpes eczema	0.36% 1/278 • 48 weeks
Skin and subcutaneous tissue disorders Rash	0.36% 1/278 • 48 weeks
Vascular disorders Fever	0.36% 1/278 • 48 weeks
Vascular disorders Hypertension	0.36% 1/278 • 48 weeks
Vascular disorders Pulmonary embolism	0.72% 2/278 • 48 weeks
Vascular disorders Shunt thrombosis	0.36% 1/278 • 48 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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