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Effect of Antacids on the Pharmacokinetics of Raltegravir

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00944307
First received: July 20, 2009
Last updated: June 26, 2017
Last verified: June 2017
July 20, 2009
June 26, 2017
July 2009
December 2009   (Final data collection date for primary outcome measure)
Raltegravir AUC with and without an antacid [ Time Frame: 0-48 hours ]
Same as current
Complete list of historical versions of study NCT00944307 on ClinicalTrials.gov Archive Site
Raltegravir Cmax with and without an antacid [ Time Frame: 0-48 hours ]
Same as current
Not Provided
Not Provided
 
Effect of Antacids on the Pharmacokinetics of Raltegravir
Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
HIV Infections
  • Drug: raltegravir
    raltegravir 400mg orally once
    Other Name: Isentress
  • Drug: antacid
    aluminum, magnesium, simethicone-containing antacid 30mL orally once
    Other Name: Isentress, Maalox Plus Extra Strength
  • Active Comparator: raltegravir alone
    Subjects will receive a single dose of 400 mg raltegravir orally
    Intervention: Drug: raltegravir
  • Experimental: raltegravir plus antacid
    Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid
    Interventions:
    • Drug: raltegravir
    • Drug: antacid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00944307
09-0475
No
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
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Jennifer J Kiser, PharmD University of Colorado, Denver
University of Colorado, Denver
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP