HIV InfectionsPhase 1NCT01930045

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

A Phase 1 study testing Raltegravir (ISENTRESS™) and MAALOX (MAL) 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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Raltegravir (ISENTRESS™) and MAALOX (MAL)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: 1 Oct 2013to 10 Dec 2013
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

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

Who cannot join

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

Show all 12Show fewer

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

About this study

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

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
Being tested: Raltegravir (ISENTRESS™), MAALOX (MAL)
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 (ISENTRESS™)Drug
Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
MAALOX (MAL)Drug
Also called MAALOX® MS
MAL (or generic equivalent) 20 mL oral single dose on Day 1

Study groups in NCT01930045
Study group	Role	What they receive
Ralt→MAL4Ralt→Ralt4MAL→MAL6Ralt→Ralt6MAL	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)
MAL4Ralt→Ralt4MAL→Ralt→MAL6Ralt→Ralt6MAL	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)
Ralt4MAL→Ralt→MAL4Ralt→MAL6Ralt→Ralt6MAL	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)
Ralt→Ralt4MAL→MAL4Ralt→Ralt6MAL→MAL6Ralt	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)
MAL4Ralt→Ralt→Ralt4MAL→Ralt6MAL→MAL6Ralt	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)
Ralt4MAL→MAL4Ralt→Ralt→Ralt6MAL→MAL6Ralt	Experimental	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 Receives: Drug: Raltegravir (ISENTRESS™); Drug: MAALOX (MAL)

What is being measured

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

Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1
Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
Measured: 12 hours after dosing on Day 1 of each period
Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1
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.
Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Maximum Plasma Concentration (C Max) of Raltegravir in Part 1
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.
Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2
Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
Measured: 12 hours after dosing on Day 1 of each period
Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2
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.
Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period
Maximum Plasma Concentration (C Max) of Raltegravir in Part 2
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.
Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

Timeline

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

1 Oct 201310 Dec 2013

First posted28 Aug 2013 (estimated)
Study start1 Oct 2013
Primary completion10 Dec 2013
Study completion10 Dec 2013

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.
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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01930045
Sponsor's protocol ID: 0518-295
Status last verified: Jul 2018
First submitted: 23 Aug 2013
Last updated: 24 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

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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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01930045
Acronym / sponsor ID: 0518-295
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Oct 2013 (actual)
Primary completion: 10 Dec 2013 (actual)
Study completion: 10 Dec 2013 (actual)
First posted: 28 Aug 2013 (estimated)
Results: Posted 3 Nov 2014

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
Ralt→MAL4Ralt→Ralt4MAL→MAL6Ralt→Ralt6MAL	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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
MAL4Ralt→Ralt4MAL→Ralt→MAL6Ralt→Ralt6MAL	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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
Ralt4MAL→Ralt→MAL4Ralt→MAL6Ralt→Ralt6MAL	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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
Ralt→Ralt4MAL→MAL4Ralt→Ralt6MAL→MAL6Ralt	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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
MAL4Ralt→Ralt→Ralt4MAL→Ralt6MAL→MAL6Ralt	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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
Ralt4MAL→MAL4Ralt→Ralt→Ralt6MAL→MAL6Ralt	Experimental	Drug: Raltegravir (ISENTRESS™), Drug: MAALOX (MAL)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

Who may qualify

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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (12 listed)

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

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 (ISENTRESS™)Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.	Drug	MAL4Ralt→Ralt4MAL→Ralt→MAL6Ralt→Ralt6MAL, MAL4Ralt→Ralt→Ralt4MAL→Ralt6MAL→MAL6Ralt, Ralt4MAL→MAL4Ralt→Ralt→Ralt6MAL→MAL6Ralt, Ralt4MAL→Ralt→MAL4Ralt→MAL6Ralt→Ralt6MAL, Ralt→MAL4Ralt→Ralt4MAL→MAL6Ralt→Ralt6MAL, Ralt→Ralt4MAL→MAL4Ralt→Ralt6MAL→MAL6Ralt
MAALOX (MAL)Also: MAALOX® MSMAL (or generic equivalent) 20 mL oral single dose on Day 1	Drug	MAL4Ralt→Ralt4MAL→Ralt→MAL6Ralt→Ralt6MAL, MAL4Ralt→Ralt→Ralt4MAL→Ralt6MAL→MAL6Ralt, Ralt4MAL→MAL4Ralt→Ralt→Ralt6MAL→MAL6Ralt, Ralt4MAL→Ralt→MAL4Ralt→MAL6Ralt→Ralt6MAL, Ralt→MAL4Ralt→Ralt4MAL→MAL6Ralt→Ralt6MAL, Ralt→Ralt4MAL→MAL4Ralt→Ralt6MAL→MAL6Ralt

Primary outcome

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
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
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
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
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
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
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.

Results and safety

Results posted to the registry on 3 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL	3	3
MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL	3	3
Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL	3	3
Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt	3	3
MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt	3	3
Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt	3	3

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Raltegravir n = 18	Maalox → 4 Hours → Raltegravir n = 17	Raltegravir → 4 Hours → Maalox n = 18
Value	241.35 (177.31 to 328.52)	96.29 (73.48 to 126.18)	92.22 (72.31 to 117.60)

Raltegravir vs Maalox → 4 Hours → Raltegravir: Geometric Mean Ratio (GMR): 0.40 (90% CI 0.31 to 0.52), p = 0.507, Hochberg step-up procedure
Raltegravir vs Raltegravir → 4 Hours → Maalox: GMR: 0.38 (90% CI 0.30 to 0.49), p = 0.624, Hochberg step-up procedure

Population analysed: The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: hr.nM

Measure	Raltegravir n = 18	Maalox → 4 Hours → Raltegravir n = 17	Raltegravir → 4 Hours → Maalox n = 18
Value	17055.21 (11625.30 to 25021.30)	13881.87 (9703.09 to 19860.30)	11602.02 (7072.82 to 19031.55)

Raltegravir vs Maalox → 4 Hours → Raltegravir: GMR: 0.81 (90% CI 0.63 to 1.05)
Raltegravir vs Raltegravir → 4 Hours → Maalox: GMR: 0.68 (90% CI 0.50 to 0.92)

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Raltegravir n = 18	Maalox → 4 Hours → Raltegravir n = 17	Raltegravir → 4 Hours → Maalox n = 18
Value	4723.00 (2837.48 to 7861.45)	3690.96 (2321.28 to 5868.82)	3324.84 (1829.19 to 6043.40)

Raltegravir vs Maalox → 4 Hours → Raltegravir: GMR: 0.78 (90% CI 0.55 to 1.10)
Raltegravir vs Raltegravir → 4 Hours → Maalox: GMR: 0.70 (90% CI 0.48 to 1.04)

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Raltegravir n = 18	Maalox → 6 Hours → Raltegravir n = 16	Raltegravir → 6 Hours → Maalox n = 16
Value	241.35 (178.78 to 325.83)	121.52 (93.99 to 157.11)	122.39 (101.28 to 147.90)

Raltegravir vs Maalox → 6 Hours → Raltegravir: GMR: 0.50 (90% CI 0.39 to 0.65)
Raltegravir vs Raltegravir → 6 Hours → Maalox: GMR: 0.51 (90% CI 0.40 to 0.64)

Population analysed: The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.

Adverse events

Time frame: Up to 84 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir	0 of 18 (0%)	0 of 18 (0%)	Not reported
Maalox → 4 Hours → Raltegravir	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
Raltegravir → 4 Hours → Maalox	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
Maalox → 6 Hours → Raltegravir	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Raltegravir → 6 Hours → Maalox	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 (ISENTRESS™) and MAALOX (MAL) 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 3 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 24 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 3 Nov 2014). 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?

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). The study lists 6 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 NCT01930045.

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 24 Aug 2018.