Effects of calcium carbonate on the absorption of raltegravir in HIV patients

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

This study tests how taking calcium carbonate with raltegravir affects how well the medication works in people living with HIV.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT04258475 on ClinicalTrials.gov

What this trial studies

This study investigates how concurrent oral calcium carbonate supplementation affects the pharmacokinetics of raltegravir, an HIV integrase inhibitor. Participants will take a standard dose of raltegravir while also receiving varying doses of calcium carbonate to assess any changes in drug absorption. The study aims to determine the optimal calcium dosage that minimizes potential drug-drug interactions. Participants will be healthy HIV-infected individuals on stable antiretroviral therapy, separated by at least 8 hours from other medications.

Who should consider this trial

Good fit: Ideal candidates are healthy HIV-infected individuals aged 18 to 65 who are on stable antiretroviral therapy with a viral load under 50 copies/mL.

Not a fit: Patients with acute illnesses or those on medications that alter drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize raltegravir absorption in HIV patients, improving treatment efficacy.

How similar studies have performed: Previous studies have indicated significant drug absorption issues with calcium carbonate, making this investigation both relevant and necessary.

Eligibility criteria

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.

Where this trial is running

Ottawa, Ontario

• The Ottawa Hospital General Campus — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Bill Cameron, MD — Ottawa Hospital Research Institute
• Study coordinator: CIU Clinical Investigation Unit

Conditions Calcium Supplementation in HIV Patients Using Raltegravir; Raltegravir; Calcium; PK