Loading clinical trials...

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

COMPLETEDPHASE1

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

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

NCT02473367•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
•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
+1 more criteria

Key Dates

Start Date

June 23, 2015

Primary Completion Date

August 29, 2015

Completion Date

October 9, 2015

Last Updated

August 27, 2018

Enrollment

ACTUAL participants

Conditions

HIV Infection

Interventions

Raltegravir 1200 mg

DRUG

TUMS

DRUG

Leader Antacid

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

View study

RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

Comprehensive HIV and Harm Prevention Via Telehealth