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

NCT01274780 | Completed Phase 4

• 1 other identifier: ATADAR
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

• Changes in total cholesterol

  24 weeks

Secondary Outcomes (8)

• Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol

  24, 48 and 96 weeks

• Cardiovascular risk according to the Framingham scale.

  24, 48 and 96 weeks.

• Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))

  24, 48 and 96 weeks

• inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin)

  24, 48 and 96 weeks

• RNA viral load <50 copies / mL

  24, 48 and 96 weeks.

Study Arms (2)

Darunavir / Ritonavir

EXPERIMENTAL

Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine

Atazanavir / Ritonavir

EXPERIMENTAL

Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine

Interventions

Darunavir / Ritonavir + Tenofovir / Emtricitabine DRUG

oral, 800/100 mg, qd + oral, 300/200 mg, qd

Darunavir / Ritonavir

Atazanavir / Ritonavir + Tenofovir / Emtricitabine DRUG

oral, 300/100 mg, qd + oral, 300/200 mg, qd

Atazanavir / Ritonavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of infection by HIV-1 (according to standard diagnostic criteria)
• Not previously treated with antiretroviral drugs
• Plasma viral load \> = 1000 copies / ml
• Able to meet the schedule of study visits and other protocol requirements
• Written informed consent to participate in the study and undergo tests and examinations that entails

You may not qualify if:

• ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal)
• serum creatinine level greater than 2 times ULN
• Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents)
• Obesity (BMI ≥ 30 kg/m2)
• Active opportunistic infection requiring intravenous treatment
• Patients with known hypersensitivity to any of the products under study
• Use of drugs formally contraindicated in the product information for any of the drugs under study
• Contraindication to the use of any of the drugs under study

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (3)

• Gonzalez-Cordon A, Domenech M, Camafort M, Martinez-Rebollar M, Torres B, Laguno M, Rojas J, Lonca M, Blanco JL, Mallolas J, Gatell JM, de Lazzari E, Martinez E. Subclinical cardiovascular disease in patients starting contemporary protease inhibitors. HIV Med. 2018 May 10. doi: 10.1111/hiv.12619. Online ahead of print.

  PMID: 29745457 DERIVED

• Martinez E, Gonzalez-Cordon A, Ferrer E, Domingo P, Negredo E, Gutierrez F, Portilla J, Curran A, Podzamczer D, Ribera E, Murillas J, Bernardino JI, Santos I, Carton JA, Peraire J, Pich J, Deulofeu R, Perez I, Gatell JM; ATADAR Study Group. Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: a randomized clinical trial. Clin Infect Dis. 2015 Mar 1;60(5):811-20. doi: 10.1093/cid/ciu898. Epub 2014 Nov 10.

  PMID: 25389256 DERIVED

• Martinez E, Gonzalez-Cordon A, Ferrer E, Domingo P, Negredo E, Gutierrez F, Portilla J, Curran A, Podzamczer D, Murillas J, Bernardino JI, Santos I, Carton JA, Peraire J, Pich J, Perez I, Gatell JM; ATADAR Study Group. Early lipid changes with atazanavir/ritonavir or darunavir/ritonavir. HIV Med. 2014 Jul;15(6):330-8. doi: 10.1111/hiv.12121. Epub 2014 Jan 12.

  PMID: 24417772 DERIVED

MeSH Terms

Interventions

Darunavir; Ritonavir; Tenofovir; Emtricitabine; Atazanavir Sulfate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical research Manager

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

ES (1)