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BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389402
First Posted: October 18, 2006
Last Update Posted: June 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoffmann-La Roche
Gilead Sciences
Information provided by:
International Antiviral Therapy Evaluation Center
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: saquinavir/ritonavir Drug: atazanavir/ritonavir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by International Antiviral Therapy Evaluation Center:

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: 120
Study Start Date: July 2006
Study Completion Date: July 2008
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389402


Locations
Netherlands
Academic Medical Centre, University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
International Antiviral Therapy Evaluation Center
Hoffmann-La Roche
Gilead Sciences
Investigators
Study Chair: Peter Reiss, MD, PhD Academic Medical Centre, University of Amsterdam, the Netherlands
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00389402     History of Changes
Other Study ID Numbers: 05-IAT-0110
Eudract number: 2006-000666-37
First Submitted: October 17, 2006
First Posted: October 18, 2006
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by International Antiviral Therapy Evaluation Center:
lipids
lipodystrophy
fat distribution
hiv-1
antiretroviral therapy
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Saquinavir
Tenofovir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors