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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01274780
First received: January 11, 2011
Last updated: September 19, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in total cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Cardiovascular risk according to the Framingham scale. [ Time Frame: 24, 48 and 96 weeks. ] [ Designated as safety issue: Yes ]
  • Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index)) [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
  • inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin) [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
  • RNA viral load <50 copies / mL [ Time Frame: 24, 48 and 96 weeks. ] [ Designated as safety issue: Yes ]
  • CD4+ cells count [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: May 2011
Estimated Study Completion Date: November 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274780

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

No publications provided by Hospital Clinic of Barcelona

Additional 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
Study First Received: January 11, 2011
Last Updated: September 19, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Ritonavir
Atazanavir
Darunavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014