DDI HV (ATV - Merck)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Merck
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00518297
First received: August 17, 2007
Last updated: February 3, 2010
Last verified: November 2008
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Purpose
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Raltegravir Drug: Atazanavir Drug: Atazanavir + Raltegravir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety Assessments [ Time Frame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge ]
- Pharmacokinetic Assessments [ Time Frame: Days 5, 12, and 26 ]
| Enrollment: | 22 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Raltegravir
Tablet, Oral, 400 mg, twice daily for 5 Days
|
| Active Comparator: 2 |
Drug: Atazanavir
Capsule, Oral, 300 mg, twice daily for 7 Days
Other Name: Reyataz
|
| Active Comparator: 3 |
Drug: Atazanavir + Raltegravir
Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
Other Name: Reyataz
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
- Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
- Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
- Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518297
Locations
| United States, New Jersey | |
| Bristol-Myers Squibb Clinical Pharmacology Unit | |
| Hamilton, New Jersey, United States, 08690 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Merck
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00518297 History of Changes |
| Other Study ID Numbers: | AI424-352 |
| Study First Received: | August 17, 2007 |
| Last Updated: | February 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Antivirals / HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Atazanavir 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 |
ClinicalTrials.gov processed this record on May 22, 2013