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	https://doi.org/10.1186/ISRCTN24813210
Secondary identifying numbers	ATAZIP

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jose Gatell
Scientific

Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Study design	Multicentre randomised open-label controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic human immunodeficiency virus (HIV) infection.
Intervention	1. Continue current therapy 2. Switch lopinavir/ritonavir to atazanavir 300 mg + ritonavir 100 mg once a day (QD)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atazanavir + ritonavir and lopinavir/ritonavir
Primary outcome measure	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	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
Overall study start date	15/02/2004
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key 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
Key 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
Date of first enrolment	15/02/2004
Date of final enrolment	31/12/2006

Infectious Diseases and HIV Unit

Barcelona
08036
Spain

Sponsor not yet defined (Spain)
Not defined

Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Industry

Bristol-Myers Squibb (BMS)
Government organisation / For-profit companies (industry)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No