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

NCT ID: NCT01930045

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2013-12-10

Brief 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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

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

Group Type: EXPERIMENTAL

Raltegravir (ISENTRESS™)

Intervention Type: DRUG

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

MAALOX (MAL)

Intervention Type: DRUG

MAL (or generic equivalent) 20 mL oral single dose on Day 1

Interventions

Raltegravir (ISENTRESS™)

Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.

Intervention Type: DRUG

MAALOX (MAL)

MAL (or generic equivalent) 20 mL oral single dose on Day 1

Intervention Type: DRUG

Other Intervention Names

MAALOX® MS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0518-295

Identifier Type: -

Identifier Source: org_study_id