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

HIV-1 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274780
• Other study ID #: ATADAR
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2011
• Last updated: December 15, 2014
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• Darunavir / Ritonavir + Tenofovir / Emtricitabine
oral, 800/100 mg, qd + oral, 300/200 mg, qd
• Atazanavir / Ritonavir + Tenofovir / Emtricitabine
oral, 300/100 mg, qd + oral, 300/200 mg, qd

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total cholesterol		24 weeks	Yes
Secondary	Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol		24, 48 and 96 weeks	Yes
Secondary	Cardiovascular risk according to the Framingham scale.		24, 48 and 96 weeks.	Yes
Secondary	Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))		24, 48 and 96 weeks	Yes
Secondary	inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin)		24, 48 and 96 weeks	Yes
Secondary	RNA viral load <50 copies / mL		24, 48 and 96 weeks.	Yes
Secondary	CD4+ cells count		24, 48 and 96 weeks	Yes
Secondary	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.		24, 48 and 96 weeks	Yes
Secondary	distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan		48 and 96 weeks	Yes