HIV InfectionsPhase 1NCT01622673

A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

A Phase 1 study testing Raltegravir, TUMS® Ultra Strength and MINTOX® Maximum Strength in people with HIV Infections, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Raltegravir, TUMS® Ultra Strength and MINTOX® Maximum Strength
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: Jun 2012to Oct 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV-infected participant on a stable raltegravir dose (400 mg every 12 hours) as part of a stable anti-retroviral regimen (ARV) for at least 1 month and will maintain current ARV therapy throughout the study
Body Mass Index ≤32 kg/m^2
Good general health
Can be a current smoker and/or user of nicotine or nicotine-containing products, but use of nicotine-containing products will not be permitted during the stay at the clinical research site

Who cannot join

History of gastric bypass surgery
Pregnant or nursing
Mentally or legally incapacitated, has significant emotional problems, or has a history of a clinically significant psychiatric disorder; participants who have had situational depression may be enrolled at the discretion of the investigator.
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding HIV); participants with a history of uncomplicated kidney stones or childhood asthma may be enrolled at the discretion of the investigator.
Active neoplastic disease deemed unstable or progressing by the investigator

Show all 12Show fewer

Currently taking rifampin or unable to refrain from use of any proton pump inhibitor and any histamine-2 (H2)-blockers, over-the-counter antacids, calcium supplements, or multivitamins during the study
Consumes excessive amounts of alcohol
Consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
Major surgery or blood donation within the past 4 weeks
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular user of any illicit drugs or history of drug (including alcohol) abuse within the past 6 months; current methadone or suboxone use is allowed.

About this study

Official title: A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen

This study will evaluate: (1) the effect of co-administration of single doses of calcium carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected participants; and (2) the effect of staggered dosing of a single dose of a magnesium/aluminum hydroxide antacid 2 hours before and 2 hours after administration of raltegravir on the steady-state plasma pharmacokinetic profile of raltegravir in the same participants.

The study will determine whether (1) the C12hrs of steady-state raltegravir after co-administration of single doses of calcium carbonate antacid is decreased to a clinically meaningful degree compared with C12hrs after administration of raltegravir alone; and whether (2) the C12hrs of steady-state raltegravir after co-administration of a single dose of magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree compared with the C12hrs after administration of raltegravir alone.

Conditions: HIV Infections
Being tested: Raltegravir, TUMS® Ultra Strength, MINTOX® Maximum Strength
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RaltegravirDrug
Also called RAL, ISENTRESS™, MK-0518
Raltegravir 400 mg oral tablet taken with 240 mL water every 12 hours
Throughout the study, participants will continue to take raltegravir along with their other HIV medications. On the day of co-dosing and intensive pharmacokinetic (PK) sampling, raltegravir will be dosed in the morning in a fasted state in all periods.
TUMS® Ultra StrengthDrug
Also called TUMS, calcium carbonate antacid
3 tablets TUMS® Ultra Strength (US) 1000 mg
Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.
MINTOX® Maximum StrengthDrug
Also called MINTOX, magnesium/aluminum hydroxide antacid
20 mL MINTOX® Maximum Strength (MS)
Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.

Study groups in NCT01622673
Study group	Role	What they receive
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours After Raltegravir in treatment period 5. There was a 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods. Receives: Drug: Raltegravir; Drug: TUMS® Ultra Strength; Drug: MINTOX® Maximum Strength

What is being measured

The primary outcome is the main question the study is designed to answer.

Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Measured: 12 hours postdose
Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Measured: 12 hours postdose
Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir
Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Number of Participants With Any Clinical or Laboratory Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Measured: Up to 7 days after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Oct 2012

First posted19 Jun 2012 (estimated)
Study startJun 2012
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01622673
Sponsor's protocol ID: 0518-247
Status last verified: Feb 2017
First submitted: 15 Jun 2012
Last updated: 21 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Kiser JJ, Bumpass JB, Meditz AL, Anderson PL, Bushman L, Ray M, Predhomme JA, Rower J, Mawhinney S, Brundage R. Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers. Antimicrob Agents Chemother. 2010 Dec;54(12):4999-5003. doi: 10.1128/AAC.00636-10. Epub 2010 Oct 4.
PubMed 20921313

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen
ClinicalTrials.gov ID: NCT01622673
Acronym / sponsor ID: 0518-247
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 19 Jun 2012 (estimated)
Results: Posted 17 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours After Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL	Experimental	Drug: Raltegravir, Drug: TUMS® Ultra Strength, Drug: MINTOX® Maximum StrengthParticipants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

HIV-infected participant on a stable raltegravir dose (400 mg every 12 hours) as part of a stable anti-retroviral regimen (ARV) for at least 1 month and will maintain current ARV therapy throughout the study
Body Mass Index ≤32 kg/m^2
Good general health
Can be a current smoker and/or user of nicotine or nicotine-containing products, but use of nicotine-containing products will not be permitted during the stay at the clinical research site

Key exclusion criteria (12 listed)

History of gastric bypass surgery
Pregnant or nursing
Mentally or legally incapacitated, has significant emotional problems, or has a history of a clinically significant psychiatric disorder; participants who have had situational depression may be enrolled at the discretion of the investigator.
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding HIV); participants with a history of uncomplicated kidney stones or childhood asthma may be enrolled at the discretion of the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RaltegravirAlso: RAL, ISENTRESS™, MK-0518Raltegravir 400 mg oral tablet taken with 240 mL water every 12 hours Throughout the study, participants will continue to take raltegravir along with their other HIV medications. On the day of co-dosing and intensive pharmacokinetic (PK) sampling, raltegravir will be dosed in the morning in a fasted state in all periods.	Drug	MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL, MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL, RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL, RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL
TUMS® Ultra StrengthAlso: TUMS, calcium carbonate antacid3 tablets TUMS® Ultra Strength (US) 1000 mg Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.	Drug	MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL, MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL, RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL, RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL
MINTOX® Maximum StrengthAlso: MINTOX, magnesium/aluminum hydroxide antacid20 mL MINTOX® Maximum Strength (MS) Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods.	Drug	MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL, MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL, RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL, RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL, TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL

Primary outcome

Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Time frame: 12 hours postdose
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Time frame: 12 hours postdose
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.
Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose
Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid
Number of Participants With Any Clinical or Laboratory Adverse Event (AE)
Time frame: Up to 7 days after the last dose of study drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.

Results and safety

Results posted to the registry on 17 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL	4	4
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL	5	4
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL	4	4
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL	6	5
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL	4	4
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL	4	4

Primary outcome: Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Time frame: 12 hours postdose. Least squares mean (95% Confidence Interval). Unit: nM

Measure	Raltegravir n = 26	TUMS® + Raltegravir n = 24	MINTOX® + Raltegravir n = 25
Value	132.30 (112)	89.75 (134)	49.38 (32.6)

Raltegravir vs TUMS® + Raltegravir: Geometric Least Squares Mean Ratio: 0.678 (90% CI 0.531 to 0.866), Mixed Models Analysis
Raltegravir vs MINTOX® + Raltegravir: Geometric Least Squares Mean Ratio: 0.373 (90% CI 0.293 to 0.475), Mixed Models Analysis

Population analysed: All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics

Primary outcome: Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Time frame: 12 hours postdose. Least squares mean (95% Confidence Interval). Unit: nM

Measure	Raltegravir n = 26	MINTOX® Before Raltegravir n = 23	MINTOX® After Raltegravir n = 23
Value	125.75 (94.33 to 167.62)	54.92 (41.36 to 72.91)	54.47 (40.95 to 72.46)

Raltegravir vs MINTOX® Before Raltegravir: Geometric Least Squares Mean Ratio: 0.437 (90% CI 0.344 to 0.554), Mixed Models Analysis
Raltegravir vs MINTOX® After Raltegravir: Geometric Least Squares Mean Ratio: 0.433 (90% CI 0.341 to 0.550), Mixed Models Analysis

Population analysed: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics

Primary outcome: Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. Least squares mean (95% Confidence Interval). Unit: nM*hr

Measure	Raltegravir n = 26	TUMS® + Raltegravir n = 24	MINTOX® + Raltegravir n = 25
Value	16399.76 (12300)	7294.30 (6690)	8358.67 (5040)

Raltegravir vs TUMS® + Raltegravir: Geometric Least Squares Mean Ratio: 0.445 (90% CI 0.350 to 0.565), Mixed Models Analysis
Raltegravir vs MINTOX® + Raltegravir: Geometric Least Squares Mean Ratio: 0.510 (90% CI 0.402 to 0.646), Mixed Models Analysis

Primary outcome: Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. Least squares mean (95% Confidence Interval). Unit: nM*hr

Measure	Raltegravir n = 26	MINTOX® Before Raltegravir n = 23	MINTOX® After Raltegravir n = 23
Value	17577.15 (13353.74 to 23136.29)	8521.95 (5572.42 to 13032.70)	12226.11 (7988.11 to 18712.53)

Raltegravir vs MINTOX® Before Raltegravir: Geometric Least Squares Mean Ratio: 0.485 (90% CI 0.351 to 0.669), Mixed Models Analysis
Raltegravir vs MINTOX® After Raltegravir: Geometric Least Squares Mean Ratio: 0.696 (90% CI 0.504 to 0.960), Mixed Models Analysis

Adverse events

Time frame: Up to 7 days after the last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir	0 of 26 (0%)	0 of 26 (0%)	Not reported
TUMS® + Raltegravir	0 of 25 (0%)	0 of 25 (0%)	Not reported
MINTOX® + Raltegravir	0 of 25 (0%)	0 of 25 (0%)	Not reported
MINTOX® Before Raltegravir	0 of 23 (0%)	0 of 23 (0%)	Not reported
MINTOX® After Raltegravir	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20921313Kiser JJ, Bumpass JB, Meditz AL, Anderson PL, Bushman L, Ray M, Predhomme JA, Rower J, Mawhinney S, Brundage R. Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers. Antimicrob Agents Chemother. 2010 Dec;54(12):4999-5003. doi: 10.1128/AAC.00636-10. Epub 2010 Oct 4.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Raltegravir, TUMS® Ultra Strength and MINTOX® Maximum Strength in people with HIV Infections, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis) (time frame: 12 hours postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01622673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.