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Sponsors and Collaborators: |
Tibotec, Inc Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
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Information provided by: | Tibotec, Inc |
ClinicalTrials.gov Identifier: | NCT00757783 |
The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a fixed background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg). This study will also evaluate the safety (adverse events), effectiveness, and tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.
Condition | Intervention | Phase |
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HIV |
Drug: darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir Drug: atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-Daily Darunavir Versus Atazanavir in HIV-Infected Treatment-naïve Adult Patients |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Active Comparator |
Drug: darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir
800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule once daily for 48 weeks
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002: Active Comparator |
Drug: atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir
300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule once daily for 48 weeks
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The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. This is a phase 4, multicenter, open-label, randomized (study drug assigned by chance), comparative study designed to compare changes in lipid, glucose, and insulin parameters in HIV-infected, anti-retroviral (ARV) naïve patients treated with DRV/r 800/100 mg once daily (QD) versus atazanavir/ritonavir (ATV/r) 300/100 mg QD in combination with a common background of emtricitabine (FTC)/ tenofovir (TDF) 200/300 mg QD. In addition, changes in inflammatory markers will be measured. A substudy of the parent study TMC114HIV4023 will evaluate insulin sensitivity and endothelial function in a subset of patients. The study will be conducted at approximately 16 study sites in the United States. Approximately 60 HIV-1 infected, treatment-naïve adult patients will be enrolled in the study. Screening will take place during a 4-week period. At the baseline visit, eligible patients will be randomized in a 1:1 ratio to receive DRV/r 800/100 mg QD or ATV/r 300/100 mg QD administered in combination with a fixed-dose background regimen consisting of emtricitabine (FTC)/tenofovir (TDF) 200/300 mg. The treatment period is 48 weeks. Study assessments will be performed at clinic visits at the end of weeks 4, 8, 12, 24, 36, and 48. The primary endpoint will be assessed at week 12. All patients will return for follow up visits 1 week and 4 weeks after the completion of study treatment. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to twenty patients (evenly randomized to receive DRV/r or ATV/r) who meet additional entry criteria will be enrolled in the substudy. The study hypothesis is the change in triglycerides and other lipids from baseline to week 12 will be similar in the DRV/r arm versus the ATV/r arm. The substudy hypothesis is that DRV/r will not adversely affect insulin sensitivity or endothelial function during 12 weeks of therapy, and the change from baseline in insulin sensitivity and endothelial function will be similar in the DRV/r arm versus the ATV/r arm.
During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring.
Patients will be randomized in a 1:1 ratio to receive darunavir/ritonavir 800/100 mg once daily (QD) plus emtricitabine (FTC)/tenofovir (TDF) 200/300 mg QD or atazanavir/ritonavir 300/100 mg QD plus emtricitabine (FTC)/tenofovir (TDF) for 48 weeks..
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
United States, California | |
Orange Coast Medical Group | Recruiting |
Newport Beach, California, United States, 92663 | |
Principal Investigator: Jorge Rodriguez | |
Not yet recruiting | |
Los Angeles, California, United States, 90033 | |
Peter J. Ruane MD, Inc. | Recruiting |
Los Angeles, California, United States, 90036 | |
Contact: Peter Ruane 323-954-1072 | |
Principal Investigator: Peter Ruane | |
United States, Connecticut | |
Not yet recruiting | |
Glastonbury, Connecticut, United States, 06033 | |
United States, District of Columbia | |
Capital Medical Associates, PC | Recruiting |
Washington, District of Columbia, United States, 20036 | |
Contact: Kelly Davis 202-822-6311 | |
Principal Investigator: Bruce Rashbaum | |
United States, Florida | |
Leonard M. Miller School of Medicine | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Dushyantha Jayaweera 305-243-3004 | |
Principal Investigator: Dushyantha Jayaweera | |
Orlando Immunology Center | Recruiting |
Orlando, Florida, United States, 32803 | |
Contact: Jeffrey Dinsmore 407-647-3960 | |
Principal Investigator: Edwin De Jesus | |
North Broward Hospital District (HIV Clinical Research) | Recruiting |
Ft Lauderdale, Florida, United States, 33311 | |
Contact: Michael Sension 954-467-0880 | |
Principal Investigator: Michael Sension | |
United States, Indiana | |
Indiana University School of Medicine | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Samir Gupta 317-274-8456 | |
Principal Investigator: SAMIR GUPTA | |
United States, Massachusetts | |
Not yet recruiting | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Not yet recruiting | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Not yet recruiting | |
Hillsborough, New Jersey, United States, 08844 | |
United States, New York | |
Not yet recruiting | |
New York, New York, United States, 10025 | |
Nyu Infectious Disease / Aids Clinical Trials Unit | Recruiting |
New York, New York, United States, 10016 | |
Contact: Janet Forcht 212-263-6565 | |
Principal Investigator: Judith Aberg | |
United States, Pennsylvania | |
Not yet recruiting | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Not yet recruiting | |
Dallas, Texas, United States, 75204 |
Study Director: | Tibotec, Inc. Clinical Trial | Tibotec, Inc |
Responsible Party: | ( Director, Clinical Development ) |
Study ID Numbers: | CR015439, TMC114HIV4023 |
Study First Received: | September 19, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00757783 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Protease Inhibitor Atazanavir PREZISTA AIDS HIV Immunodeficiency Virus, Human |
TMC114 darunavir Truvada REYATAZ HIV Infections Treatment Naïve |
HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Darunavir Reverse Transcriptase Inhibitors |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents Emtricitabine HIV Infections Ritonavir Tenofovir Tenofovir disoproxil |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Atazanavir Enzyme Inhibitors Antiviral Agents Darunavir Pharmacologic Actions |
Reverse Transcriptase Inhibitors Protease Inhibitors Emtricitabine Anti-Retroviral Agents Ritonavir Therapeutic Uses Tenofovir Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |