Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
This study is ongoing, but not recruiting participants.
Sponsor:
New York University School of Medicine
Collaborators:
Bellevue/NYU AIDS Clinical Trials Unit
Kowa Pharmaceuticals America, Inc.
University at Buffalo
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01695954
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia HIV |
Drug: Pitavastatin Drug: Darunavir Drug: Ritonavir Drug: Efavirenz |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | THE EFFECT OF EFAVIRENZ AND RITONAVIR-BOOSTED DARUNAVIR ON THE PHARMACOKINETICS OF THE HMG CoA REDUCTASE INHIBITOR PITAVASTATIN |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- AUC of pitavastatin after coadministration of efavirenz. AUC of pitavastatin after coadministration of darunavir with ritonavir. AUC of efavirenz after coadministration of pitavastatin. AUC of darunavir after coadministration of pitavastatin. [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]24-hour area under the curve (AUC)
Secondary Outcome Measures:
- Other pharmacokinetic parameters of pitavastatin and efavirenz and of pitavastatin and darunavir+ritonavir. Lipid measurements at days 0,4,14 and 18. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
- Other pharmacokinetic parameters of pitavastatin and efavirenz such as Cmax, Cmin, Tmax, and T1/2.
- Other pharmacokinetic parameters of pitavastatin and darunavir+ritonavir such as Cmax, Cmin, Tmax, and T1/2.
- At days 0, 4, 14 and 18: Fasting HDL, total cholesterol, LDL and triglycerides for patients in Arm A.
- At days 0, 4, 14 and 18: Fasting HDL, total cholesterol, LDL and triglycerides for patients in Arm B.
| Enrollment: | 28 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A: (Pitavastatin and Efavirenz)
Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime and efavirenz 600 mg at bedtime.
|
Drug: Pitavastatin
Pitavastatin 2 mg tablets taken at bedtime in Arm A and in the morning in Arm B.
Other Name: Livalo
Drug: Efavirenz
Efavirenz 600 mg tablets taken at bedtime in Arm A
Other Name: Sustiva
|
|
Experimental: Arm B: (Pitavastatin and Ritonavir-boosted Darunavir)
Subjects assigned to Arm B will receive pitavastatin 2 mg daily and darunavir 800 mg with ritonavir 100 mg daily.
|
Drug: Pitavastatin
Pitavastatin 2 mg tablets taken at bedtime in Arm A and in the morning in Arm B.
Other Name: Livalo
Drug: Darunavir
Darunavir 400 mg tablets x 2 taken daily in Arm B
Other Name: Prezista
Drug: Ritonavir
Ritonavir 100 mg tablets taken daily in Arm B
Other Name: Norvir
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
- Male or female aged 18-60 years.
- Able and willing to provide informed consent.
- All men and women of reproductive potential must practice adequate birth control to prevent pregnancy from start of the study until completion of the study.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.
- Hemoglobin > 12.5 g/dL for men; > 11.5 g/dL for women;
- Absolute neutrophil count >1,500 cells/mm3;
- Platelet count > 100,000 platelets/mm3;
- AST (SGOT)/ALT (SGPT) <1.5X ULN;
- Creatinine <1.5 X ULN
- Subject is within 20% (+/-) of ideal body weight and must weigh at least 50 kg
Exclusion Criteria:
- Use of illicit drugs or alcohol which would interfere with the completion of this study.
- Pregnancy or breast-feeding.
- History of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions which might interfere with drug absorption.
- Any medical condition which, in the opinion of the investigator, would interfere with the subjects ability to participate in this protocol.
- Use of prohibited protocol-specified drugs, prescription or over-the-counter within 14 days prior to study entry.
- Participation in any investigational drug studies within 30 days prior to study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695954
Locations
| United States, New York | |
| Bellevue/NYU AIDS Clinical Trials Unit | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
New York University School of Medicine
Bellevue/NYU AIDS Clinical Trials Unit
Kowa Pharmaceuticals America, Inc.
University at Buffalo
Investigators
| Principal Investigator: | Judith Aberg, M.D. | NYU School of Medicine |
More Information
No publications provided
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01695954 History of Changes |
| Other Study ID Numbers: | NYU 11-01787 |
| Study First Received: | September 26, 2012 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
HIV Hyperlipidemia Pharmacokinetics Statins |
Darunavir Efavirenz Pitavastatin |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ritonavir Darunavir Efavirenz Pitavastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors 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 Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013