Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Juan A. Arnaiz
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01274780
First received: January 11, 2011
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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).
Condition | Intervention | Phase |
---|---|---|
HIV-1 |
Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Darunavir
Atazanavir sulfate
Darunavir ethanolate
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Changes in total cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- Cardiovascular risk according to the Framingham scale. [ Time Frame: 24, 48 and 96 weeks. ] [ Designated as safety issue: Yes ]
- Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index)) [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin) [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- RNA viral load <50 copies / mL [ Time Frame: 24, 48 and 96 weeks. ] [ Designated as safety issue: Yes ]
- CD4+ cells count [ Time Frame: 24, 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: Yes ]
Enrollment: | 180 |
Study Start Date: | January 2011 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | Juan A. Arnaiz, Clinical research Manager, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT01274780 History of Changes |
Other Study ID Numbers: | ATADAR |
Study First Received: | January 11, 2011 |
Last Updated: | August 1, 2012 |
Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
Ritonavir Atazanavir Darunavir Tenofovir Tenofovir disoproxil Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on October 18, 2012