HIV InfectionPhase 1NCT02473367

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

A Phase 1 study testing Raltegravir 1200 mg, TUMS and Leader Antacid in people with HIV Infection, 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

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Trial summary

In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: Raltegravir 1200 mg, TUMS and Leader Antacid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 23 Jun 2015to 9 Oct 2015
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

Is HIV positive
Is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (ARV) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current ARV therapy throughout the study.
Be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening)
Has a Body Mass Index (BMI) =< 32 kg/m^2

Who cannot join

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding HIV)
Has a history of gastric bypass surgery
Has a history of cancer (malignancy)
Has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-trial visit

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Has participated in another investigational trial within 4 weeks prior to the pre-trial visit
Is currently taking rifampin or atazanavir or is unable to refrain from the use of 1) any proton pump inhibitor from two weeks prior to the study through the completion of Period 4, and 2) any H2-blockers, over-the-counter antacids, calcium supplements or multivitamins from one week prior to the study through the completion of Period 4
Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day
Consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
Is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months of screening

About this study

Official title: A Study to Evaluate the Influence of Metal Cation-Containing Antacids on MK-0518 Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen

Conditions: HIV Infection
Being tested: Raltegravir 1200 mg, TUMS, Leader Antacid
Medical subject headings: HIV Infections

What participants receive

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

Raltegravir 1200 mgDrug
Two tablets of 600 mg raltegravir administered orally, once daily, over 5 days of Pre-treatment, and once at the start of Periods 1-4.
TUMSDrug
Three tablets of TUMS Ultra Strength (US) 1000, taken orally, concomitantly with raltegravir in Period 2, and 12 hours after raltegravir in Period 4
Leader AntacidDrug
20 mL Leader Antacid Maximum Strength (MS) taken orally 12 hours after raltegravir, in Period 3

Study groups in NCT02473367
Study group	Role	What they receive
Raltegravir Pre- and 4 Period Sequence	Experimental	Starting five days prior to Period 1 participants will be treated with 1200 mg raltegravir, once daily for five days. In Period 1 participants will be treated with 1200 raltegravir alone; this is followed by Period 2 where participants will be treated with 1200 mg raltegravir and TUMS concomitantly; this is followed by Period 3 where participants will be treated with 1200 mg raltegravir and 12 hours later with Leader Antacid; followed by Period 4 where participants will be treated with 1200 mg raltegravir and 12 hours later with TUMS. The wait between Periods is 2-7 days. Receives: Drug: Raltegravir 1200 mg; Drug: TUMS; Drug: Leader Antacid

What is being measured

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

Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.
Measured: 24 hours post-dose

Timeline

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

23 Jun 20159 Oct 2015

First posted16 Jun 2015 (estimated)
Study start23 Jun 2015
Primary completion29 Aug 2015
Study completion9 Oct 2015

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 InfectionStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02473367
Sponsor's protocol ID: 0518-824
Status last verified: Jul 2018
First submitted: 12 Jun 2015
Last updated: 27 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Krishna R, East L, Larson P, Valiathan C, Butterfield K, Teng Y, Hernandez-Illas M. Effect of metal-cation antacids on the pharmacokinetics of 1200 mg raltegravir. J Pharm Pharmacol. 2016 Nov;68(11):1359-1365. doi: 10.1111/jphp.12632. Epub 2016 Sep 27.
PubMed 27671833

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

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Influence of Metal Cation-Containing Antacids on MK-0518 Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen
ClinicalTrials.gov ID: NCT02473367
Acronym / sponsor ID: 0518-824
Conditions: HIV Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 23 Jun 2015 (actual)
Primary completion: 29 Aug 2015 (actual)
Study completion: 9 Oct 2015 (actual)
First posted: 16 Jun 2015 (estimated)
Results: Posted 1 Sep 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Raltegravir Pre- and 4 Period Sequence	Experimental	Drug: Raltegravir 1200 mg, Drug: TUMS, Drug: Leader AntacidStarting five days prior to Period 1 participants will be treated with 1200 mg raltegravir, once daily for five days. In Period 1 participants will be treated with 1200 raltegravir alone; this is followed by Period 2 where participants will be treated with 1200 mg raltegravir and TUMS concomitantly; this is followed by Period 3 where participants will be treated with 1200 mg raltegravir and 12 hours later with Leader Antacid; followed by Period 4 where participants will be treated with 1200 mg raltegravir and 12 hours later with TUMS. The wait between Periods is 2-7 days.

Who may qualify

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

Key inclusion criteria (4 listed)

Is HIV positive
Is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (ARV) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current ARV therapy throughout the study.
Be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening)
Has a Body Mass Index (BMI) =< 32 kg/m^2

Key exclusion criteria (11 listed)

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding HIV)
Has a history of gastric bypass surgery
Has a history of cancer (malignancy)
Has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

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
Raltegravir 1200 mgTwo tablets of 600 mg raltegravir administered orally, once daily, over 5 days of Pre-treatment, and once at the start of Periods 1-4.	Drug	Raltegravir Pre- and 4 Period Sequence
TUMSThree tablets of TUMS Ultra Strength (US) 1000, taken orally, concomitantly with raltegravir in Period 2, and 12 hours after raltegravir in Period 4	Drug	Raltegravir Pre- and 4 Period Sequence
Leader Antacid20 mL Leader Antacid Maximum Strength (MS) taken orally 12 hours after raltegravir, in Period 3	Drug	Raltegravir Pre- and 4 Period Sequence

Primary outcome

Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.
Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.
Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir
Time frame: 24 hours post-dose
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Four Period Fixed Sequence	20	20

Primary outcome: Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose. Least squares mean (95% Confidence Interval). Unit: hr*µM

Measure	Period 1: Raltegravir Only n = 20	Period 2: Raltegravir + TUMS Concomitantly n = 19	Period 3: Raltegravir + 12 Hrs Leader Antacid n = 19	Period 4: Raltegravir + 12 Hrs TUMS n = 19
Value	53.7 (44.2 to 65.2)	14.8 (12.4 to 17.7)	46.3 (36.0 to 59.6)	48.5 (39.0 to 60.3)

Period 1: Raltegravir Only vs Period 2: Raltegravir + TUMS Concomitantly: Geom. least-squares mean ratio (GLSMR): 0.28 (90% CI 0.24 to 0.32)
Period 1: Raltegravir Only vs Period 3: Raltegravir + 12 Hrs Leader Antacid: GLSMR: 0.86 (90% CI 0.73 to 1.03)
Period 1: Raltegravir Only vs Period 4: Raltegravir + 12 Hrs TUMS: GLSMR: 0.90 (90% CI 0.80 to 1.03)

Population analysed: Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.

Primary outcome: Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose. Least squares mean (95% Confidence Interval). Unit: nM

Measure	Period 1: Raltegravir Only n = 20	Period 2: Raltegravir + TUMS Concomitantly n = 19	Period 3: Raltegravir + 12 Hrs Leader Antacid n = 19	Period 4: Raltegravir + 12 Hrs TUMS n = 19
Value	20000 (16500 to 24300)	5240 (4230 to 6490)	17300 (12800 to 23300)	19500 (15900 to 24000)

Period 1: Raltegravir Only vs Period 2: Raltegravir + TUMS Concomitantly: GLSMR: 0.26 (90% CI 0.21 to 0.32)
Period 1: Raltegravir Only vs Period 3: Raltegravir + 12 Hrs Leader Antacid: GLSMR: 0.86 (90% CI 0.65 to 1.15)
Period 1: Raltegravir Only vs Period 4: Raltegravir + 12 Hrs TUMS: GLSMR: 0.98 (90% CI 0.81 to 1.17)

Primary outcome: Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir

Time frame: 24 hours post-dose. Least squares mean (95% Confidence Interval). Unit: nM

Measure	Period 1: Raltegravir Only n = 20	Period 2: Raltegravir + TUMS Concomitantly n = 19	Period 3: Raltegravir + 12 Hrs Leader Antacid n = 19	Period 4: Raltegravir + 12 Hrs TUMS n = 19
Value	75.6 (55.3 to 103)	39.6 (29.9 to 52.5)	32.0 (23.7 to 43.2)	32.4 (24.6 to 42.6)

Period 1: Raltegravir Only vs Period 2: Raltegravir + TUMS Concomitantly: GLSMR: 0.52 (90% CI 0.45 to 0.61)
Period 1: Raltegravir Only vs Period 3: Raltegravir + 12 Hrs Leader Antacid: GLSMR: 0.42 (90% CI 0.34 to 0.52)
Period 1: Raltegravir Only vs Period 4: Raltegravir + 12 Hrs TUMS: GLSMR: 0.43 (90% CI 0.36 to 0.51)

Adverse events

Time frame: Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: Raltegravir Only	0 of 20 (0%)	9 of 20 (45%)	Not reported
Period 2: Raltegravir + TUMS Concomitantly	1 of 19 (5.3%)	4 of 19 (21.1%)	Not reported
Period 3: Raltegravir + 12 Hrs Leader Antacid	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Period 4: Raltegravir + 12 Hrs TUMS	1 of 19 (5.3%)	5 of 19 (26.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27671833Krishna R, East L, Larson P, Valiathan C, Butterfield K, Teng Y, Hernandez-Illas M. Effect of metal-cation antacids on the pharmacokinetics of 1200 mg raltegravir. J Pharm Pharmacol. 2016 Nov;68(11):1359-1365. doi: 10.1111/jphp.12632. Epub 2016 Sep 27.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Raltegravir 1200 mg, TUMS and Leader Antacid in people with HIV Infection, 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 11 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 27 Aug 2018. 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 1 Sep 2016). 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?

Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir (time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose). The study lists 3 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 NCT02473367, 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 27 Aug 2018.