BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes
This study has been completed.
Information provided by:
International Antiviral Therapy Evaluation Center
First received: October 17, 2006
Last updated: June 10, 2010
Last verified: June 2010
The purpose of this study is to assess differences in changes in plasma lipids between patients on saquinavir/ritonavir or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine as a first-line regimen in patients previously naive for antiretroviral therapy. This study is an extension from the SSAR 2004/0002 which randomised patients over the same treatment arms.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Randomised, Controlled, Open-Label, 48-Week, Study To Asses Differences in Changes In Plasma Lipid Profile Between Patients On Saquinavir/Ritonavir Or Atazanavir/Ritonavir In Combination With Tenofovir Disoproxil Fumarate And Emtricitabine As A First-line Regimen.
Primary Outcome Measures:
- To assess the differences in changes in plasma lipids after once-daily saquinavir/ritonavir (2000/100 mg) or atazanavir/ritonavir (300/100 mg) each in combination with tenofovir disoproxil fumarate (300 mg QD) and emtricitabine (200 mg QD) for 24 weeks
Secondary Outcome Measures:
- To assess the differences in changes in plasma lipids after once-daily saquinavir/ritonavir (2000/100 mg QD) or atazanavir/ritonavir (300/100 mg QD) each in combination with tenofovir disoproxil fumarate and emtricitabine for 48 weeks.
- To compare differences in changes in glucose metabolism.
- To compare changes in fat redistribution in both study arms.
- To relate differences in changes in lipids, glucose metabolism and abdominal fat distribution to the plasma exposure of the different protease inhibitors (including ritonavir) used in the trial.
- To assess the change in estimated glomerular filtration rate (GFR) by Cockcroft-Gault, MDRD and cystatin C-derived equations in both study arms.
- To compare the antiviral efficacy of both regimens.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Providing written informed consent
- HIV-1 infected patients.
- At least 18 years of age.
- Males or non-pregnant, non-lactating females. Women of childbearing age must have a negative urine pregnancy test at screening. All female participants must be encouraged to utilise adequate contraception for the month preceding entry and for the duration of the study.
- Anti-retroviral treatment naive.
- Indication for antiretroviral therapy according to current treatment guidelines.
- CD4 count > 350 cells/mm3, except in case of symptomatic HIV disease and/or an AIDS-defining illness.
- HIV-2 co infection.
- Use of co-medication with a known pharmacological interaction which precludes the appropriate use of one or more of the study drugs.
- Anticipated non-compliance with the protocol.
- Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study.
- Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. Patients who may be considered to have active HBV replication (HBV-surface antigen positive and/or HBV-DNA positive) may be excluded in case the investigator feels that the benefit of starting tenofovir/emtricitabine does not outweigh the risk of a "hepatitis flare" in case tenofovir/emtricitabine would need to be prematurely discontinued for any reason during the trial. Chronic hepatitis C is allowed, provided that treatment for hepatitis C is not anticipated during the study period.
- Women who are pregnant, or have the intention to become pregnant during the study period.
- Clinically relevant laboratory abnormalities: anaemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase, which in the opinion of the investigator is a contraindication for the use of any of the study drugs, or any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 2). However, asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate. Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrolment.
- Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis)
Note: The site will calculate each patient's CrCl using the Cockcroft-Gault formula as shown below:
CrCl = [140 - age (yr)] × weight (kg) × constant 72 × serum creatinine (Cr) (mg/dL) where, constant = 1 for men and 0.85 for women.
- Use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate and any other of the study drugs.
- Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.
- Patients who have taken any investigational drug 30 days prior to the start of the study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00389402
|Academic Medical Centre, University of Amsterdam
|Amsterdam, Netherlands, 1105 AZ |
International Antiviral Therapy Evaluation Center
||Peter Reiss, MD, PhD
||Academic Medical Centre, University of Amsterdam, the Netherlands
No publications provided
History of Changes
|Other Study ID Numbers:
||05-IAT-0110, Eudract number: 2006-000666-37
|Study First Received:
||October 17, 2006
||June 10, 2010
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by International Antiviral Therapy Evaluation Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2015
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action