Chronic human immunodeficiency virus (HIV) infection. Infections and Infestations Asymptomatic human immunodeficiency virus [HIV] infection status
Conditions
Interventions
1. Continue current therapy
2. Switch lopinavir/ritonavir to atazanavir 300 mg + ritonavir 100 mg once a day (QD)
Sponsors
Sponsor not yet defined (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female 2. HIV-1 infection 3. Age 18 and above 4. On antiretroviral therapy including lopinavir/ritonavir for at least 6 months 5. Viral load <200 copies/ml for at least 3 months 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding, intention to become pregnant during study period 2. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >/= 5 x upper limit of normal (ULN); creatinine >/= 2.0 mg/dl; total bilirubin >/= 3 x ULN 3. Alcoholism or drug abuse potentially impairing adherence or increasing risk of pancreatitis or hepatitis 4. Any formal contraindication to receive the study drugs 5. Active heart conduction alterations or long QTc or electrocardiogram (ECG) suggesting atrioventricular (AV) block 6. Patients with five or more mutations of resistance to protease inhibitors (PIs) 7. Patients with more than two virological failures to PIs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with two consecutive viral load determinations above 200 copies/ml (polymerase chain reaction [PCR] estándar, Amplicor Monitor Roche) during the study period (12 months after randomization). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean increase in CD4 counts 2. Incidence of adverse events (clinical and laboratory) leading to treatment discontinuation 3. Changes in lipid profile (cholesterol, triglyceride) and insulin resistance 4. Anthropometric changes 5. Incidence of C events (CDC 1993) 6. Death for any cause | — |
Countries
Spain
Outcome results
None listed