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

December 15, 2014 updated by: Juan A. Arnaiz

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in total cholesterol
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol
Time Frame: 24, 48 and 96 weeks
24, 48 and 96 weeks
Cardiovascular risk according to the Framingham scale.
Time Frame: 24, 48 and 96 weeks.
24, 48 and 96 weeks.
Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))
Time Frame: 24, 48 and 96 weeks
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
24, 48 and 96 weeks
RNA viral load <50 copies / mL
Time Frame: 24, 48 and 96 weeks.
24, 48 and 96 weeks.
CD4+ cells count
Time Frame: 24, 48 and 96 weeks
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
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
48 and 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan A. Arnaiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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