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The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.

NCT04258475 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-12-12

No results posted yet for this study

Summary

The purpose of this study is to measure change in raltegravir serum pharmacokinetics in steady state, when co-administered with calcium carbonate formulated as antacid.

Conditions

  • Calcium Supplementation in HIV Patients Using Raltegravir

Interventions

DRUG

Raltegravir standard dosage of 1200 mg (two 600 mg tablets) orally once daily.

Raltegravir will be dosed in a fasted state in all periods. Participants will take Raltegravir along with other ART medication.

DRUG

Calcium carbonate antacid tablet

PK analysis of different doses of calcium carbonate antacid in patients undergoing ART treatment for HIV using Raltegravir.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Bill Cameron, MD · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2024-06-15
Completion
2025-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258475 on ClinicalTrials.gov