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
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 |
|---|---|
| dpodzamczer@csub.scs.es |
Study information
| Study design | Randomized, open, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nevirapine |
| Primary outcome measure | 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 study start date | 30/04/2004 |
| Completion date | 30/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 308 (154 per arm) |
| 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
08907
Spain
Sponsor information
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Av. Gran via s/n km 2,7
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| Website | http://www.idibell.es |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
