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

January 11, 2011
September 19, 2013
May 2011
May 2013   (final data collection date for primary outcome measure)
Changes in total cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01274780 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
Not Provided

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1
  • Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine
    oral, 800/100 mg, qd + oral, 300/200 mg, qd
  • Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine
    oral, 300/100 mg, qd + oral, 300/200 mg, qd
  • Experimental: Darunavir / Ritonavir
    Intervention: Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine
  • Experimental: Atazanavir / Ritonavir
    Intervention: Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
November 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01274780
ATADAR
No
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Not Provided
Hospital Clinic of Barcelona
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP