View Clinical Trial (Medical Research Study)
Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers
| City: |
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Aurora |
| State: |
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Colorado |
| Zip Code: |
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80045 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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 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
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| NCT ID: |
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NCT00944307 |
| Primary Contact: |
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Principal Investigator
Jennifer J Kiser, PharmD
University of Colorado, Denver
Jennifer J Kiser, PharmD
Phone: 303-724-6131
Email: jennifer.kiser@ucdenver.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Aurora, Colorado 80045
United States
Jennifer J Kiser, PharmD
Phone: 303-724-6131
Email: jennifer.kiser@ucdenver.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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