BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes
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ClinicalTrials.gov Identifier: NCT00389402 |
Recruitment Status
:
Completed
First Posted
: October 18, 2006
Last Update Posted
: June 11, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: saquinavir/ritonavir Drug: atazanavir/ritonavir | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
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. |
Study Start Date : | July 2006 |
Actual Study Completion Date : | July 2008 |

- 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
- 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.

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

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
Netherlands | |
Academic Medical Centre, University of Amsterdam | |
Amsterdam, Netherlands, 1105 AZ |
Study Chair: | Peter Reiss, MD, PhD | Academic Medical Centre, University of Amsterdam, the Netherlands |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00389402 History of Changes |
Other Study ID Numbers: |
05-IAT-0110 Eudract number: 2006-000666-37 |
First Posted: | October 18, 2006 Key Record Dates |
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 |