NCT01274780CompletedPhase 4
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
Juan A. Arnaiz1 site in 1 country180 target enrollmentStarted: May 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Changes in total cholesterol
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Clinically stable patients in the investigator's opinion at the time of inclusion
- •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
Exclusion Criteria
- •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)
- •Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study.
- •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
- •Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test
Arms & Interventions
Darunavir / Ritonavir
Experimental
Intervention: Darunavir / Ritonavir + Tenofovir / Emtricitabine (Drug)
Atazanavir / Ritonavir
Experimental
Intervention: Atazanavir / Ritonavir + Tenofovir / Emtricitabine (Drug)
Outcomes
Primary Outcomes
Changes in total cholesterol
Time Frame: 24 weeks
Secondary Outcomes
- 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.)
- CD4+ cells count(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.(24, 48 and 96 weeks)
- distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan(48 and 96 weeks)
Investigators
Juan A. Arnaiz
Clinical research Manager
Hospital Clinic of Barcelona
Study Sites (1)
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