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.

Completed

• Conditions: Human immunodeficiency virus (HIV) infection; Infections and Infestations; Human immunodeficiency virus (HIV)

• Registration Number: ISRCTN81305260
• Lead Sponsor: Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 308

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified