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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
ISRCTN ISRCTN24813210
DOI 10.1186/ISRCTN24813210
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source ATAZIP
Study hypothesis Comparison of the effectiveness and tolerability when switching lopinavir/ritonavir to atazanavir + ritonavir in HIV-1-infected patients on lopinavir/ritonavir and viral load <200 copies/ml.
Lay summary
Ethics approval Not provided at time of registration
Study design Multicentre randomised open-label controlled trial
Countries of recruitment Spain
Disease/condition/study domain Chronic human immunodeficiency virus (HIV) infection.
Participants - 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
Participants - 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
Anticipated start date 15/02/2004
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 300
Interventions 1. Continue current therapy
2. Switch lopinavir/ritonavir to atazanavir 300 mg + ritonavir 100 mg once a day (QD)
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Bristol-Myers Squibb (BMS)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19390327
Contact name Dr  Jose  Gatell
  Address Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
Sponsor Sponsor not yet defined (Spain)
  Address Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
Date applied 12/09/2005
Last edited 04/08/2009
Date ISRCTN assigned 20/01/2006
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