A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)

HIV Infections Clinical Trial

Official title:

A Study to Evaluate the Effect of Staggered Dosing of a Magnesium/Aluminum Antacid on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Raltegravir-Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930045
• Other study ID #: 0518-295
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2013
• Est. completion date: December 10, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 10, 2013
• Est. primary completion date: December 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
• MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1	Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.	12 hours after dosing on Day 1 of each period
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1	Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.	Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Primary	Maximum Plasma Concentration (C Max) of Raltegravir in Part 1	Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.	Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Primary	Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2	Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.	12 hours after dosing on Day 1 of each period
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2	Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.	Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Primary	Maximum Plasma Concentration (C Max) of Raltegravir in Part 2	Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.	Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period