Randomised, multicentre, open clinical trial assessing the effectiveness and safety of simplification to atazanavir + ritonavir versus continuation of a stable antiretroviral regimen on lopinavir/ritonavir
- Conditions
- Chronic human immunodeficiency virus (HIV) infection.Infections and InfestationsAsymptomatic human immunodeficiency virus [HIV] infection status
- Registration Number
- ISRCTN24813210
- Lead Sponsor
- Sponsor not yet defined (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Mean increase in CD4 counts<br>2. Incidence of adverse events (clinical and laboratory) leading to treatment discontinuation<br>3. Changes in lipid profile (cholesterol, triglyceride) and insulin resistance<br>4. Anthropometric changes<br>5. Incidence of C events (CDC 1993)<br>6. Death for any cause