The effect of antacids and multivitamins on raltegravir (RalpH)
Research type
Research Study
Full title
A 3 arm, 5 phase study to determine the effect of divalent and monovalent metal-containing antacids and multivitamins on the pharmacokinetics of raltegravir in healthy volunteers
IRAS ID
109063
Contact name
Saye Khoo
Contact email
Eudract number
2013-000278-31
Clinicaltrials.gov Identifier
Research summary
HIV remains a worldwide health concern. New drug treatments are needed to treat patients with drug-resistant HIV. Raltegravir is a new medication which shows impressive anti-HIV properties and low toxicity in patients.
Raltegravir blood exposure is reduced when co-administered with divalent-metal-containing antacid treatments, which may lead to the development of drug resistance. It is believed that the metals in the antacid are reducing the absorption of raltegravir. There are no previous studies which have assessed the effects of metal-containing multivitamins on raltegravir exposure in patients.
This study aims to determine the effects of metal-containing antacids and multivitamins on the exposure of raltegravir. The influence of gastrointestinal pH on raltegravir exposure will also be determined using pH-measuring radiotelemetry capsules. The results from this study will be used to improve current raltegravir therapy in HIV patients, by preventing sub-optimal drug concentrations. The study will be conducted in 15 healthy volunteers.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0257
Date of REC Opinion
5 Jul 2013
REC opinion
Further Information Favourable Opinion