Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
20/01/2006
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Gatell

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ATAZIP

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised open-label controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Atazanavir + ritonavir and lopinavir/ritonavir

Primary outcome measures

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 trial start date

15/02/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

15/02/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Infectious Diseases and HIV Unit
Barcelona
08036
Spain

Sponsor information

Organisation

Sponsor not yet defined (Spain)

Sponsor details

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

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Bristol-Myers Squibb (BMS)

Alternative name(s)

Bristol-Myers Squibb Company, BMS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19390327

Publication citations

  1. Results

    Mallolas J, Podzamczer D, Milinkovic A, Domingo P, Clotet B, Ribera E, Gutiérrez F, Knobel H, Cosin J, Ferrer E, Arranz JA, Roca V, Vidal F, Murillas J, Pich J, Pedrol E, Llibre JM, Dalmau D, García I, Aranda M, Cruceta A, Martínez E, Blanco JL, Lazzari Ed, Gatell JM, , Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study., J. Acquir. Immune Defic. Syndr., 2009, 51, 1, 29-36, doi: 10.1097/QAI.0b013e31819a226f.

Additional files

Editorial Notes