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
Secondary identifying numbers NODy-03
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

Study designRandomized, open, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleHighly 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 acronymNODy
Study objectivesPatients 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) studiedHuman immunodeficiency virus (HIV) infection
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nevirapine
Primary outcome measureProportion of patients with ALT or aspartate aminotransferase (AST) more than or equal to grade three (more than five times above normal values)
Secondary outcome measures1. 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
Overall study start date30/04/2004
Completion date30/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants308 (154 per arm)
Total final enrolment289
Key inclusion criteria1. 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 criteria1. 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 enrolment30/04/2004
Date of final enrolment30/12/2006

Locations

Countries of recruitment

  • Spain

Study participating centre

HIV Unit
Barcelona
08907
Spain

Sponsor information

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Hospital/treatment centre

Av. Gran via s/n km 2,7
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Website http://www.idibell.es
ROR logo "ROR" https://ror.org/0008xqs48

Funders

Funder type

Industry

Boehringer Ingelheim, Spain

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.