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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81305260

Enrollment

308

Registered

2006-07-28

Start date

2004-04-30

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) infection Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

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 rando

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026