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Effect of Antacids on the Pharmacokinetics of Raltegravir

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: raltegravir (Drug); antacid (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Jennifer J Kiser, PharmD, Principal Investigator, Affiliation: University of Colorado, Denver

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.

Clinical Details

Official title: Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Raltegravir AUC with and without an antacid

Secondary outcome: Raltegravir Cmax with and without an antacid

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

University of Colorado Denver, Aurora, Colorado 80045, United States
Additional Information

Starting date: July 2009
Last updated: June 6, 2014

Page last updated: August 23, 2015

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