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Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274780
First Posted: January 12, 2011
Last Update Posted: December 16, 2014
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.
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
  Purpose

This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels.

Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥ 4.5).


Condition Intervention Phase
HIV-1 Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in total cholesterol [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol [ Time Frame: 24, 48 and 96 weeks ]
  • Cardiovascular risk according to the Framingham scale. [ Time Frame: 24, 48 and 96 weeks. ]
  • Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index)) [ Time Frame: 24, 48 and 96 weeks ]
  • inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin) [ Time Frame: 24, 48 and 96 weeks ]
  • RNA viral load <50 copies / mL [ Time Frame: 24, 48 and 96 weeks. ]
  • CD4+ cells count [ Time Frame: 24, 48 and 96 weeks ]
  • clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms. [ Time Frame: 24, 48 and 96 weeks ]
  • distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan [ Time Frame: 48 and 96 weeks ]

Enrollment: 180
Study Start Date: May 2011
Study Completion Date: January 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darunavir / Ritonavir Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine
oral, 800/100 mg, qd + oral, 300/200 mg, qd
Experimental: Atazanavir / Ritonavir Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine
oral, 300/100 mg, qd + oral, 300/200 mg, qd

  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:

  1. Patients of both sexes aged 18 years or more. Women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study.
  2. Diagnosis of infection by HIV-1 (according to standard diagnostic criteria)
  3. Not previously treated with antiretroviral drugs
  4. Plasma viral load > = 1000 copies / ml
  5. Clinically stable patients in the investigator's opinion at the time of inclusion
  6. Able to meet the schedule of study visits and other protocol requirements
  7. Written informed consent to participate in the study and undergo tests and examinations that entails

Exclusion Criteria:

  1. ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal)
  2. serum creatinine level greater than 2 times ULN
  3. Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents)
  4. Obesity (BMI ≥ 30 kg/m2)
  5. Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study.
  6. Active opportunistic infection requiring intravenous treatment
  7. Patients with known hypersensitivity to any of the products under study
  8. Use of drugs formally contraindicated in the product information for any of the drugs under study
  9. Contraindication to the use of any of the drugs under study
  10. Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test
  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): NCT01274780


Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan A. Arnaiz, Clinical research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01274780     History of Changes
Other Study ID Numbers: ATADAR
First Submitted: January 11, 2011
First Posted: January 12, 2011
Last Update Posted: December 16, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Ritonavir
Darunavir
Atazanavir Sulfate
Tenofovir
Emtricitabine
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


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