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Antiretroviral Medication

Raltegravir and Calcium Supplementation Interaction in HIV Treatment (RCPK Trial)

Phase 4
Recruiting
Led By Mary-Anne Doyle, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be between the ages of 18 and 65.
Patient must be a healthy HIV infected male or female.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
Awards & highlights

RCPK Trial Summary

This trial looks at how an HIV drug interacts with an antacid to affect its effectiveness.

Who is the study for?
This trial is for healthy HIV-infected men and women aged 18-65, with a stable viral load under 50 copies/mL. They must be on effective antiretroviral therapy that's compatible with the study drugs or can be timed around them. Participants need to avoid herbal products two weeks before and during the study.Check my eligibility
What is being tested?
The trial tests how taking calcium carbonate (an antacid) affects the levels of Raltegravir, an HIV medication, in the blood when they are taken together. The goal is to see if calcium changes how well Raltegravir works.See study design
What are the potential side effects?
Possible side effects may include those commonly associated with antacids like stomach upset or constipation, as well as any known side effects of Raltegravir such as headache, difficulty sleeping, or dizziness.

RCPK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am HIV positive but otherwise healthy.

RCPK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Steady-state serum pharmacokinetics analysis of raltegravir in patients undergoing ART treatment (with raltegravir) and concurrent calcium supplementation.
Secondary outcome measures
24-hour concentration (Cmin, Ctrough) of raltegravir PK parameter analysis within study duration within study duration.
Area-under-the-time-concentration curve from 0 to 24 hours PK parameter analysis within study duration.
Elimination half-life PK parameter analysis within study duration.
+2 more

RCPK Trial Design

1Treatment groups
Experimental Treatment
Group I: Raltegravir-Calcium PK measureExperimental Treatment2 Interventions
Period 1: Raltegravir 1200 mg alone; Period 2: Calcium carbonate antacid 500 mg and 1200 mg of raltegravir given concomitantly; Period 3: two tablets of calcium carbonate antacid 500 mg and 1200 mg of raltegravir given concomitantly. Patients will have a total of 8 visits during the study. Day 1 visit: Raltegravir 1200 mg oral daily until day 7. Day 7 visit: Timed serial phlebotomy before dosing t(0) and 0.5, 1, 1.5, 2, 3, 4, 6 hours after observed dosing. Day 8 visit: 24 h PK sampling followed by Raltegravir 1200 mg + Calcium carbonate 500 mg oral daily until day 14. Day 14 visit: Timed serial phlebotomy before dosing t(0) and 0.5, 1, 1.5, 2, 3, 4, 6 hours after observed dosing. Day 15 visit: 24 h PK Sampling followed by Raltegravir 1200 mg + Calcium carbonate 1000 mg oral daily until day 21. Day 21 visit: Timed serial phlebotomy before dosing t(0) and 0.5, 1, 1.5, 2, 3, 4, 6 hours after observed dosing. Day 22 visit: 24 h PK Sampling. Day 51 visit: Final safety visit.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,482 Total Patients Enrolled
Mary-Anne Doyle, MDPrincipal InvestigatorOttawa Hospital Research Institute
Bill Cameron, MDPrincipal InvestigatorOttawa Hospital Research Institute
2 Previous Clinical Trials
206 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored in this clinical experiment?

"Affirmative, according to the information on clinicaltrials.gov this trial is currently recruiting patients. It was initially published on December 9th 2020 and edited as recently as November 9th 2023. The objective of the study is to enrol 12 participants from a single medical facility."

Answered by AI

Is the age criterion for this research project restricted to individuals under 30 years of age?

"As part of the qualification parameters, this clinical trial has established an age range for potential participants: 18 and 65 years old."

Answered by AI

Is my participation in this research endeavor possible?

"This clinical trial is seeking 12 individuals, aged 18-65 and taking calcium supplements. Furthermore, they must be medically stable, HIV positive (with a viral load of < 50 copies/mL), willing to cease using herbal or natural health products for two weeks before the study begins and during its duration, capable of reading and signing an informed consent form prior to initiation of the research project, compatible with once daily raltegravir dose or able to separate it from calcium administration by at least 8 hours in twice-a-day dosing schedule."

Answered by AI

Are enrollments still open for this trial?

"As of right now, clinicaltrials.gov reports that this study is actively attempting to enroll patients. The trial was first publicized on December 9th 2020 and the last update occurred November 9th 2023."

Answered by AI

Has the FDA endorsed Raltegravir-Calcium's pharmacokinetic metrics?

"As this therapy has already been approved, our Power team estimates its safety to be a 3 on the 1-3 scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.
2020. "The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258475.
~0 spots leftby Jun 2024
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