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

Juan A. Arnaiz

Status and phase: Completed; Phase 4

Conditions: HIV-1

Treatments: Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine; Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01274780

ATADAR

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Darunavir / Ritonavir

Experimental group

Treatment:

Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine

Atazanavir / Ritonavir

Experimental group

Treatment:

Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine