A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | June 2012 |
| End Date: | October 2012 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen
This study will evaluate: (1) the effect of co-administration of single doses of calcium
carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma
pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected
participants; and (2) the effect of staggered dosing of a single dose of a
magnesium/aluminum hydroxide antacid 2 hours before and 2 hours after administration of
raltegravir on the steady-state plasma pharmacokinetic profile of raltegravir in the same
participants.
The study will determine whether (1) the C12hrs of steady-state raltegravir after
co-administration of single doses of calcium carbonate antacid is decreased to a clinically
meaningful degree compared with C12hrs after administration of raltegravir alone; and
whether (2) the C12hrs of steady-state raltegravir after co-administration of a single dose
of magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree
compared with the C12hrs after administration of raltegravir alone.
Inclusion Criteria:
- HIV-infected male or female, 18 or more years of age, on a stable raltegravir dose
(400 mg every 12 hours [q12h]) as part of a stable anti-retroviral regimen (ARV) for
at least 1 month and will maintain current ARV therapy throughout the study
- Body Mass Index (BMI) ≤32 kg/m^2
- Good general health
- Can be a current smoker and/or user of nicotine or nicotine-containing products, but
use of nicotine-containing products will not be permitted during the stay at the
clinical research site
Exclusion Criteria:
- History of gastric bypass surgery
- Pregnant or nursing
- Mentally or legally incapacitated, has significant emotional problems, or has a
history of a clinically significant psychiatric disorder; participants who have had
situational depression may be enrolled at the discretion of the investigator.
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular,
hematological, hepatic, immunological, renal, respiratory, or genitourinary
abnormalities or diseases (excluding HIV); participants with a history of
uncomplicated kidney stones or childhood asthma may be enrolled at the discretion of
the investigator.
- Active neoplastic disease deemed unstable or progressing by the investigator
- Currently taking rifampin or unable to refrain from use of any proton pump inhibitor
and any histamine-2 (H2)-blockers, over-the-counter antacids, calcium supplements, or
multivitamins during the study
- Consumes excessive amounts of alcohol
- Consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
- Major surgery or blood donation within the past 4 weeks
- History of significant multiple and/or severe allergies or has had an anaphylactic
reaction or significant intolerability to prescription or non-prescription drugs or
food
- Regular user of any illicit drugs or history of drug (including alcohol) abuse within
the past 6 months; current methadone or suboxone use is allowed.
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