Highly active anti-retroviral therapy including nevirapine once daily versus twice daily after at least 12 weeks of nevirapine twice daily. A randomized, open, multicentre trial.

ISRCTN	ISRCTN81305260
DOI	https://doi.org/10.1186/ISRCTN81305260
Protocol serial number	NODy-03
Sponsor	Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Funder	Boehringer Ingelheim, Spain

Submission date: 13/07/2006
Registration date: 28/07/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Podzamczer
Scientific

HIV Unit
Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Phone	+34 (0)93 260 7668
Email	dpodzamczer@csub.scs.es

Study information

Primary study design	Interventional
Study design	Randomized, open, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Highly active anti-retroviral therapy including nevirapine once daily versus twice daily after at least 12 weeks of nevirapine twice daily. A randomized, open, multicentre trial.
Study acronym	NODy
Study objectives	Patients tolerating a standard nevirapine regimen for at least 12 weeks will not present greater hepatic toxicity if switched to a once daily regimen comparing with continuing the standard twice a day (bid) regimen.
Ethics approval(s)	Approved 18/12/2003 by the Medicine Spanish Agency and the ethics boards of all participating hospitals.
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV) infection
Intervention	Patients will be stratified according to whether their CD4 level is more than, equal to or less than 200 cells/ul and whether they are hepatitis C virus (HCV) positive or negative, and centrally randomized to one of these arms: 1. Switch to nevirapine 400 mg once daily 2. Continue with nevirapine 200 mg bid
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nevirapine
Primary outcome measure(s)	Proportion of patients with ALT or aspartate aminotransferase (AST) more than or equal to grade three (more than five times above normal values)
Key secondary outcome measure(s)	1. Time to ALT and time to AST to reach more than five times above baseline values 2. Virological (virological rebound), immunological (CD4 response) and clinical (progression to acquired immune deficiency syndrome [AIDS]) efficacy 3. Clinical hepatitis
Completion date	30/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	308
Total final enrolment	289
Key inclusion criteria	1. Human immunodeficiency virus (HIV)-positive confirmed by Western blot 2. Adult 18 years or over 3. Under treatment with a highly active anti-retroviral therapy (HAART) regimen including nevirapine 200 mg bid for at least 12 weeks. Females with cluster of differentiation subset four molecules (CD4) >250 cells/ul need to have been receiving the nevirapine bid regimen for at least 18 weeks. 4. Alanine aminotransferase (ALT) <2.5 times the upper limit normal 5. Undetectable viral load (with the test used in each center) 6. Written informed consent
Key exclusion criteria	1. Concomitant participation in another clinical trial 2. Clinical suspicion of hepatic cirrhosis 3. Renal failure with creatinine clearance <50 ml/min 4. Any of the following laboratory parameter alterations: amylases more than three times above normal values, haemoglobin <8 mg/dl, neutrophils <500 cells/ul, platelets <30,000/ul 5. Pregnancy 6. Active infection within the last four weeks 7. Treatment for neoplasms 8. Treatment with methadone
Date of first enrolment	30/04/2004
Date of final enrolment	30/12/2006

Locations

Countries of recruitment

Spain

Study participating centre

HIV Unit

Barcelona
08907
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.