Pilot study of simplification with fosamprenavir/ritonavir (FPV/r) monotherapy

Completed

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

• Registration Number: ISRCTN78584791
• 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: 2008-12-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult human immunodeficiency virus (HIV) infected patients (greater than 18 years, either gender)
2. Receiving a highly active anti-retroviral therapy (HAART) regimen including FPV/r (for at least four weeks) and two nucleoside/nucleotide analogues
3. Without previous failure with protease inhibitor regimens
4. Viral load less than 40 copies/mL for at least six months
5. CD4 counts greater than 100 cells/uL at inclusion

Exclusion Criteria

1. Previous virologic failure (confirmed or suspected) while receiving a PI-based regimen
2. Alanine aminotransferase (ALT) greater than 5 x upper limit of normal
3. Clinical suspicion of cirrosis
4. Renal insufficiency with glomerular filtrate less than 50 ml/min
5. Haemoglobin less than 9 g/dl
6. Neutrophils less than 1000/mm^3
7. Platelets less than 30,000 /mm^3
8. Pregnant women or no contraceptive measures
9. Active infection in the two weeks prior to inclusion in the study
10. Systemic therapy for neoplasms
11. Patients with positive hepatitis B surface antigens (HBsAg) receiving tenofovir and/or lamiduvine

Study & Design

• Study Type: Interventional
• Study Design: Not specified