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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 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
HIV Infections
Drug: raltegravir
Drug: antacid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Raltegravir AUC with and without an antacid [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Raltegravir Cmax with and without an antacid [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: raltegravir alone
Subjects will receive a single dose of 400 mg raltegravir orally
Drug: raltegravir
raltegravir 400mg orally once
Other Name: Isentress
Experimental: raltegravir plus antacid
Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944307

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jennifer J Kiser, PharmD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00944307     History of Changes
Other Study ID Numbers: 09-0475
Study First Received: July 20, 2009
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
HIV
antiretroviral
drug interaction
human immunodeficiency virus

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Antacids
Anti-Ulcer Agents
TEMPO
Antioxidants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014