Raltegravir/Calcium Study

Overview

Raltegravir is an antiretroviral (ART) medication used in combination with other drugs to treat HIV/AIDS. Calcium supplementation it is often recommended for persons with HIV due to bone mineral density loss associated with aging, and with other medications including ART. High dose of calcium is reported to reduce Raltegravir level. The standard currently is a lower dose of Calcium, so we would like to know if lower doses of calcium (500-1000 mg) will have any effect on Raltegravir levels.The patient population will consist of volunteers who are taking ART with good virological and immunological treatment effect and are willing and able to separate once-daily ART dosing from study medications of raltegravir and calcium by taking their ART medications in the evening and study medications in the morning, at least 8 hours apart. Each study participant will take two oral raltegravir 600 mg tablets once daily for three one-week periods and have three end-week PK days of a 7-hour housing, observed dosing around a standardized meal, and serial 6-hour phlebotomy with 24 hour follow-up phlebotomy. Persons will take concurrent calcium carbonate one or two 500 mg tablets together with raltegravir during breakfast in the second or third week respectively. Safety, tolerance and adherence by returned pill count will be documented at each study visit. Patients who are already taking Raltegravir as part of their ART plan can be recruited and their medication schedule will be personally supervised and planned by the Study Physician.

Full Title of Study: “On the Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

Interventions

  • Combination Product: Calcium supplementation concurrent to HIV treatment with Raltegravir
    • PK analysis of different doses of calcium in patients undergoing ART treatment for HIV using Raltegravir.

Arms, Groups and Cohorts

  • Experimental: Raltegravir-Calcium PK measure
    • Patients will have a total of 8 visits during the study after initial screening visit to gauge patient eligibility: Day 1 visit: Oral administration of Raltegravir. Day 7 visit: Oral administration of Raltegravir and Calcium 500 mg in the morning. Timed serial Phlebotomy at .5, 1, 1.5, 2, 3, 4, 6, 24 hours after observed dosing (see visit day 8). Day 8 visit: day 7’s 24 hour phlebotomy visit. Day 14 visit: Oral administration of Raltegravir and Calcium 1000 mg in the morning. Timed serial Phlebotomy at .5, 1, 1.5, 2, 3, 4, 6, 24 hours after observed dosing (see visit day 15). Day 15 visit: Day 14’s 24 hour phlebotomy visit. Day 21 visit: Timed serial Phlebotomy at .5, 1, 1.5, 2, 3, 4, 6, 24 hours after observed dosing (see visit day 22). Day 22 visit: Day 21’s 24 hour phlebotomy visit. Day 51: Final safety visit. Follow-up for patient safety and data collection from diary.

Clinical Trial Outcome Measures

Primary Measures

  • Analysis of Calcium concentration in the blood of patients using calcium supplementation while concurrently undergoing ART treatment with Raltegravir
    • Time Frame: 22 days
    • to determine the steady state, minimum (C24h) serum concentration of raltegravir 24 hours after dosing of raltegravir 1200 mg, when administered concomitantly with calcium carbonate 500 mg or 1000 mg, and when administered 12 hours apart.

Secondary Measures

  • maximum plasma concentration PK parameter analysis within study duration.
    • Time Frame: 22 days
    • To determine other pharmacokinetic measures including time from observed dosing to maximum plasma concentration, under the same conditions as the primary objectives.
  • maximum concentration PK parameter analysis within study duration.
    • Time Frame: 22 days
    • To determine pharmacokinetic measure of maximum concentration under the same conditions as the primary objectives.
  • area-under-the-time-concentration curve from 0 to 24 hours PK parameter analysis within study duration.
    • Time Frame: 22 days
    • To determine pharmacokinetic measure of area-under-the-time-concentration curve from 0 to 24 hours under the same conditions as the primary objectives.
  • elimination half-life PK parameter analysis within study duration.
    • Time Frame: 22 days
    • To determine pharmacokinetic measure of elimination half-life under the same conditions as the primary objectives.
  • 24-hour concentration (Cmin, Ctrough) of raltegravir PK parameter analysis within study duration within study duration.
    • Time Frame: 22 days
    • To determine pharmacokinetic measure of the 24-hour concentration (Cmin, Ctrough) of raltegravir under the same conditions as the primary objectives.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mary-Anne Doyle, MD, Principal Investigator, Ottawa Hospital Research Institute
  • Overall Contact(s)
    • CIU Clinical Investigation Unit, 613-737-8811, iseguin@toh.ca

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