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

NCT ID: NCT01274780

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Darunavir / Ritonavir

Group Type EXPERIMENTAL

Darunavir / Ritonavir + Tenofovir / Emtricitabine

Intervention Type DRUG

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

Atazanavir / Ritonavir

Group Type EXPERIMENTAL

Atazanavir / Ritonavir + Tenofovir / Emtricitabine

Intervention Type DRUG

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

Interventions

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Darunavir / Ritonavir + Tenofovir / Emtricitabine

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

Intervention Type DRUG

Atazanavir / Ritonavir + Tenofovir / Emtricitabine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juan A. Arnaiz

OTHER

Sponsor Role lead

Responsible Party

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Juan A. Arnaiz

Clinical research Manager

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 29745457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25389256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24417772 (View on PubMed)

Other Identifiers

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ATADAR

Identifier Type: -

Identifier Source: org_study_id