Effect of Antacids on the Pharmacokinetics of Raltegravir

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; Antacids; Anti-Ulcer Agents; Raltegravir Potassium; TEMPO

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