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 October 23, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action