CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Raltegravir 1200 mg +2 moredrug
Likely dose
Raltegravir 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02473367
NCT02473367Phase 1Completed
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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

Merck Sharp & Dohme LLC·interventional·Posted Jun 16, 2015·Updated Aug 27, 2018

In Brief

A Phase 1 clinical trial evaluating Raltegravir 1200 mg, TUMS, and 1 other intervention for HIV Infection. Completed, enrolled 20 participants.

Detailed 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 participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2015
Enrollment StartJun 23, 2015
Primary CompletionAug 29, 2015
Study CompletionOct 9, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.0 years ago

Interventions

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