a pharmacokinetic study to evaluate the effect of antacids on raltegravir (mk-0518) in hiv-infected participants (mk-0518-247)

Conditions: HIV Infections

Summary: 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.


Eligibility criteria:
inclusion criteria: * hiv-infected participant on a stable raltegravir dose (400 mg every 12 hours) 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 ≤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.