A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-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: October 29, 2014
Last verified: October 2014

August 23, 2013
October 29, 2014
October 2013
December 2013   (final data collection date for primary outcome measure)
  • Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1 [ Time Frame: 12 hours after dosing on Day 1 of each period ] [ Designated as safety issue: No ]
    Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
  • Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1 [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ] [ Designated as safety issue: No ]
    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.
  • Maximum Plasma Concentration (C Max) of Raltegravir in Part 1 [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ] [ Designated as safety issue: No ]
    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.
  • Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2 [ Time Frame: 12 hours after dosing on Day 1 of each period ] [ Designated as safety issue: No ]
    Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
  • Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2 [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ] [ Designated as safety issue: No ]
    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.
  • Maximum Plasma Concentration (C Max) of Raltegravir in Part 2 [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ] [ Designated as safety issue: No ]
    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.
  • 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 ]
Complete list of historical versions of study NCT01930045 on ClinicalTrials.gov Archive Site
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A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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: Ralt→MAL4Ralt→Ralt4MAL→MAL6Ralt→Ralt6MAL
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
  • Experimental: MAL4Ralt→Ralt4MAL→Ralt→MAL6Ralt→Ralt6MAL
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
  • Experimental: Ralt4MAL→Ralt→MAL4Ralt→MAL6Ralt→Ralt6MAL
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
  • Experimental: Ralt→Ralt4MAL→MAL4Ralt→Ralt6MAL→MAL6Ralt
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
  • Experimental: MAL4Ralt→Ralt→Ralt4MAL→Ralt6MAL→MAL6Ralt
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
  • Experimental: Ralt4MAL→MAL4Ralt→Ralt→Ralt6MAL→MAL6Ralt
    Part 1 was comprised of periods 1, 2 and 3; Part 2 was comprised of 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 period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
    Interventions:
    • Drug: Raltegravir (ISENTRESS™)
    • Drug: MAALOX (MAL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01930045
0518-295
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP