A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir (ISENTRESS™); MAALOX (MAL)
Intervention description: Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.; MAL (or generic equivalent) 20 mL oral single dose on Day 1
Intervention MeSH terms: Raltegravir Potassium; Aluminum hydroxide, magnesium hydroxide, drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX)
      given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of
      raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted
      of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period
      separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a
      Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1
      pharmacokinetics results before continuing to Part 2. The same participants participated in
      Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma
      concentration 12 hours after administration (C 12 hrs) would not differ significantly from
      raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after
      raltegravir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On a stable raltegravir dose as part of a stable antiretroviral regimen for ≥1 month
             before the study

          -  If female, is not pregnant or breast feeding

          -  Body mass index ≤32 kg/m^2

        Exclusion Criteria:

          -  Mentally or physically incapacitated, has significant emotional problems, or history
             of clinically significant psychiatric disorder within ≤10 years

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or major
             neurological abnormalities or disease (excluding HIV)

          -  History of gastric bypass surgery

          -  History of cancer, except adequately treated non-melanomatous skin carcinoma or
             carcinoma in situ of the cervix or other malignancies which have been successfully
             treated ≥10 years before the study

          -  History of chronic diarrhea within ≤3 months before the study

          -  History of significant multiple and/or severe allergies (food, drug, latex), or had an
             anaphylactic reaction or significant intolerability to drugs or food

          -  Had major surgery or donated or lost ≥1 unit of blood (500 mL) ≤4 weeks before the
             study

          -  Participated in another investigational trial ≤4 weeks before the study

          -  Taking rifampin or is unable to refrain from the use of 1) any proton pump inhibitor
             from 2 weeks before and throughout the study, or 2) any histamine H2-blockers,
             antacids, calcium supplements, or multivitamins from 2 weeks before and throughout the
             study

          -  Consumes >3 glasses of alcoholic beverages per day

          -  Consumes excessive amounts of caffeine beverages (coffee, tea, cola, energy drinks, or
             other caffeinated drinks) per day

          -  Currently uses or has a history of drug abuse within ≤6 months before the study