Recruiting

Raltegravir with Calcium Carbonate

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04258475

Conditions

Calcium Supplementation in HIV Patients Using Raltegravir

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

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

Calcium carbonate antacid tablet

Study Details

Brief 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

Study ID

NCT04258475

Start date

Dec 9, 2020

Status verified date

Nov, 2023

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Jun 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient must be a healthy HIV infected male or female.
2. Patient must be between the ages of 18 and 65.
3. Patient must be undergoing stable effective ART and must be compatible with once a-day study raltegravir or be separable from study calcium co-administration by at least 8 hours in a twice-a-day dosing schedule.
4. Patient must have a viral load < 50 copies/mL within 3 months of study Day 1.
5. Patient must be medically stable at time of study, with no evidence of acute illness as per physician assessment.
6. Patient must be able to read, understand and sign a written informed consent prior to initiation of the study.
7. Patients must be willing to stop using any herbal or natural health products for 2 weeks prior to Day 1 and during the study.

Exclusion Criteria:

1. Patient on any medications that can alter the drug absorption of study medications other than oral contraception and stable effective ART. This includes no micronutrient mineral and trace element supplementation (except calcium).
2. Patient donated blood with the 30 days prior to study start.
3. Persons with prior gastric or enteric surgery, acute medical illness, or anticipated use of other medications, supplements or treatments.
4. Patient has a BMI > 30
5. Patient is unable to understand, consent and adhere to study protocol and procedures.
6. Women who are pregnant, breast-feeding, and not willing to practice contraception during the study period plus one month.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Raltegravir-Calcium PK measure

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.

Interventions

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.

Calcium carbonate antacid tablet

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

Primary outcome measure

  • Steady-state serum pharmacokinetics analysis of raltegravir in patients undergoing ART treatment (with raltegravir) and concurrent calcium supplementation. [ Time Frame: 22 days ]

Central Contacts and Locations

Central contacts

CIU Clinical Investigation Unit

613-737-8811CIU@ohri.ca

Locations

The Ottawa Hospital General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Principal Investigator:

Bill Cameron, M.D

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Dec 12, 2023

Last verified

Nov, 2023

Keywords

  • Raltegravir
  • Calcium
  • PK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2023-12-12.