Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus
Conditions
Interventions
Fosamprenavir/ritonavir 700/100 mg twice daily (BID). The duration of the study is 48 weeks. After the end of the study period, FPV/r monotherapy will be continued or not according to physicians crite
same for semen samples at 0, 24 and 48 weeks
4. Genotype resistance tests if patients with viral load greater than 500 copies/mL throughout the study period
Sponsors
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with plasma viral load less than 40 copies/mL at 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Viral load in CSF and semen, in CSF sample at 24 weeks and in semen samples at 0, 24 and 48 weeks 2. FPV levels in CSF and semen, in CSF sample at 24 weeks and in semen samples at 0, 24 and 48 weeks 3. Correlation between FPV plasma viral load and virological and immunological responses 4. Immunological outcome (CD4 and CD8) at weeks 0, 4, 12, 24, 32, 40 and 48 5. Lipid changes at weeks 0, 4, 12, 24, 32, 40 and 48 6. Adherence to therapy (GEEMA questionnaire), every visit | — |
Countries
Spain
Outcome results
None listed