ISRCTN - ISRCTN81305260: 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.

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Podzamczer

ORCID ID

Contact details

HIV Unit
Infectious Disease Service
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
+34 (0)93 260 7668
dpodzamczer@csub.scs.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NODy-03

Study information

Scientific title

Acronym

NODy

Study hypothesis

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

Approved 18/12/2003 by the Medicine Spanish Agency and the ethics boards of all participating hospitals.

Study design

Randomized, open, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Nevirapine

Primary outcome measures

Proportion of patients with ALT or aspartate aminotransferase (AST) more than or equal to grade three (more than five times above normal values)

Secondary outcome measures

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

Overall trial start date

30/04/2004

Overall trial end date

30/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

308 (154 per arm)

Participant 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

Recruitment start date

30/04/2004

Recruitment end date

30/12/2006

Locations

Countries of recruitment

Spain

Trial participating centre

HIV Unit
Barcelona
08907
Spain

Sponsor information

Organisation

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)