Back to resultsEffect of Antacids on the Pharmacokinetics of Raltegravir
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
raltegravir
antacid
Sponsored by
About this trial
This is an interventional basic science trial for HIV Infections focused on measuring HIV, antiretroviral, drug interaction, human immunodeficiency virus
Eligibility Criteria
Inclusion Criteria:
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
- Age greater than or equal to 18 but less than or equal to 60 years.
- Ability and willingness to give written informed consent.
- Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
- Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
- Creatine kinase (CK) less than 3 times the upper limit of normal
Exclusion Criteria:
- Pregnancy or breast-feeding.
- Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
- Allergy/sensitivity to raltegravir.
- Allergy/sensitivity to antacids.
- Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
- Participation in any investigational drug studies within 30 days prior to study entry.
- History of or active cardiovascular, renal, hematologic, hepatic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that might interfere with drug absorption.
- Use of investigational, prescription, and over-the-counter medications within 14 days of study entry with the following exceptions: aspirin, acetaminophen, ibuprofen, and oral contraceptives
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
raltegravir alone
raltegravir plus antacid
Arm Description
Subjects will receive a single dose of 400 mg raltegravir orally
Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid
Outcomes
Primary Outcome Measures
Raltegravir AUC with and without an antacid
Secondary Outcome Measures
Raltegravir Cmax with and without an antacid
Full Information
NCT ID
NCT00944307
First Posted
July 20, 2009
Last Updated
June 26, 2017
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00944307
Brief Title
Effect of Antacids on the Pharmacokinetics of Raltegravir
Official Title
Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
Detailed Description
This study will determine if an interaction occurs between the HIV medicine raltegravir and an antacid. A prior study found an interaction with another medicine like raltegravir called elvitegravir and an antacid. The elvitegravir levels were reduced by half. The same interaction may occur with raltegravir and an antacid based on the structure of this medicine and how it works. When the levels of HIV medications are reduced, people with HIV can "fail" their treatment. The virus can multiply when the drug levels are too low and the medications can stop working. We need to be sure that antacids will not cause this problem with raltegravir.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, antiretroviral, drug interaction, human immunodeficiency virus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
raltegravir alone
Arm Type
Active Comparator
Arm Description
Subjects will receive a single dose of 400 mg raltegravir orally
Arm Title
raltegravir plus antacid
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid
Intervention Type
Drug
Intervention Name(s)
raltegravir
Other Intervention Name(s)
Isentress
Intervention Description
raltegravir 400mg orally once
Intervention Type
Drug
Intervention Name(s)
antacid
Other Intervention Name(s)
Isentress, Maalox Plus Extra Strength
Intervention Description
aluminum, magnesium, simethicone-containing antacid 30mL orally once
Primary Outcome Measure Information:
Title
Raltegravir AUC with and without an antacid
Time Frame
0-48 hours
Secondary Outcome Measure Information:
Title
Raltegravir Cmax with and without an antacid
Time Frame
0-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
Age greater than or equal to 18 but less than or equal to 60 years.
Ability and willingness to give written informed consent.
Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
Creatine kinase (CK) less than 3 times the upper limit of normal
Exclusion Criteria:
Pregnancy or breast-feeding.
Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
Allergy/sensitivity to raltegravir.
Allergy/sensitivity to antacids.
Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
Participation in any investigational drug studies within 30 days prior to study entry.
History of or active cardiovascular, renal, hematologic, hepatic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that might interfere with drug absorption.
Use of investigational, prescription, and over-the-counter medications within 14 days of study entry with the following exceptions: aspirin, acetaminophen, ibuprofen, and oral contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Kiser, PharmD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Antacids on the Pharmacokinetics of Raltegravir
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