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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01930045
First received: August 23, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

This study will evaluate the effect of single doses of a magnesium/aluminum antacid (MAALOX) before or after administration of raltegravir on the pharmacokinetics of raltegravir in human immunodeficiency virus (HIV)-infected participants. The study will consist of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5). Each study period will have a duration of ≥2 days, and the study will pause for evaluation of Part 1 pharmacokinetics results before continuing to Part 2. The same participants will participate in Parts 1 and 2. The primary hypothesis being tested (in Part 1) is that raltegravir plasma concentration 12 hours after administration (C 12 hrs) will not differ significantly from raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after raltegravir.


Condition Intervention Phase
HIV Infections
Drug: Raltegravir (ISENTRESS™)
Drug: MAALOX (MAL)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma Concentration of Raltegravir (C 12 hrs) in Part 1 [ Time Frame: 12 hours after dosing on Day 1 of each period in Part 1 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration versus Time Curve of Raltegravir (AUC 0-12 hrs) in Part 1 [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing on Day 1 of each period in Part 1 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of Raltegravir (C max) in Part 1 [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing on Day 1 of each period in Part 1 ] [ Designated as safety issue: No ]
  • Plasma Concentration of Raltegravir (C 12 hrs) in Part 2 [ Time Frame: 12 hours after raltegravir dosing on Day 1 of each period in Part 2 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration versus Time Curve of Raltegravir (AUC 0-12 hrs) in Part 2 [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing on Day 1 of each period in Part 2 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of Raltegravir (C max) in Part 2 [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing on Day 1 of each period in Part 2 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Raltegravir alone in Period 1, MAALOX (MAL) followed 4 hrs later by Raltegravir in Period 2, Raltegravir followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Raltegravir in Period 4, Raltegravir followed 6 hrs later by MAL in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS
Experimental: Sequence 2
MAL followed 4 hrs later by Raltegravir in Period 1, Raltegravir followed 4 hrs later by MAL in Period 2, Raltegravir alone in Period 3, MAL followed 6 hrs later by Raltegravir in Period 4, Raltegravir followed 6 hrs later by MAL in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS
Experimental: Sequence 3
Raltegravir followed 4 hrs later by MAL in Period 1, Raltegravir alone in Period 2, MAL followed 4 hrs later by Raltegravir in Period 3, MAL followed 6 hrs later by Raltegravir in Period 4, Raltegravir followed 6 hrs later by MAL in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS
Experimental: Sequence 4
Raltegravir alone in Period 1, Raltegravir followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Raltegravir in Period 3, Raltegravir followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Raltegravir in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS
Experimental: Sequence 5
MAL followed 4 hrs later by Raltegravir in Period 1, Raltegravir alone in Period 2, Raltegravir followed 4 hrs later by MAL in Period 3, Raltegravir followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Raltegravir in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS
Experimental: Sequence 6
Raltegravir followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Raltegravir in Period 2, Raltegravir alone in Period 3, Raltegravir followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Raltegravir in Period 5
Drug: Raltegravir (ISENTRESS™)
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
Drug: MAALOX (MAL)
MAL (or generic equivalent) 20 mL oral single dose on Day 1
Other Name: MAALOX® MS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01930045     History of Changes
Other Study ID Numbers: 0518-295
Study First Received: August 23, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Aluminum hydroxide, magnesium hydroxide, drug combination
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014