A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir; TUMS® Ultra Strength; MINTOX® Maximum Strength
Intervention description: Raltegravir 400 mg oral tablet taken with 240 mL water every 12 hours
Throughout the study, participants will continue to take raltegravir along with their other HIV medications. On the day of co-dosing and intensive pharmacokinetic (PK) sampling, raltegravir will be dosed in the morning in a fasted state in all periods.; 3 tablets TUMS® Ultra Strength (US) 1000 mg
Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.; 20 mL MINTOX® Maximum Strength (MS)
Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.
Intervention MeSH terms: Raltegravir Potassium; Calcium Carbonate; Aluminum Hydroxide; Antacids; Aluminum hydroxide, magnesium hydroxide, drug combination; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; Anti-Ulcer Agents; TEMPO
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.