Raltegravir and Calcium Supplementation Interaction in HIV Treatment

(RCPK Trial)

Overseen By CIU Clinical Investigation Unit

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must be taking: Antiretrovirals

Must not be taking: Micronutrients, Minerals

Disqualifiers: BMI > 30, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bill Cameron, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I am on a stable HIV treatment that fits with the study's medication schedule.

I am HIV positive but otherwise healthy.

I am willing to stop taking herbal or natural products 2 weeks before and during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants take raltegravir 1200 mg alone daily for 7 days with serial PK measures

1 week

2 visits (in-person)

Treatment Period 2

Participants take raltegravir 1200 mg with 500 mg calcium carbonate daily for 7 days with serial PK measures

1 week

2 visits (in-person)

Treatment Period 3

Participants take raltegravir 1200 mg with 1000 mg calcium carbonate daily for 7 days with serial PK measures

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Calcium
• Raltegravir

Trial Overview 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.

Participant Groups

Group I: Raltegravir-Calcium PK measure Experimental Treatment 2 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.

Raltegravir is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as Isentress for:

• HIV infection in adults and children

Approved in European Union as Isentress for:

• HIV infection in adults and children

Approved in United States as Isentress HD for:

• HIV infection in adults and children weighing at least 40 kg

Approved in United Kingdom as Raltegravir for:

• HIV infection in adults and pediatric patients weighing at least 40 kg

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+