A Clinical Study Investigating Rifampicin and Dolutegravir in Combination in Healthy Volunteers — RADIO  

Tuberculosis Clinical Trial

Official title: Phase One, Open Lab Study to Investigate the Impact of Rifampicin Administration on the PK of Dolutegravir When Dosed Once Daily at 50 or 100 mg in Healthy Volunteers

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to see how the drug Dolutegravir is broken down by your body, when taken with another drug called Rifampicin. Dolutegravir is given to people as a treatment for HIV. Rifampicin is given to people as a treatment for tuberculosis.

Clinical Trial Description

The integrase inhibitor under investigation in this study, Dolutegravir (DTG), is relatively new to the market only having been approved in 2014. DTG is now being used on a large scale to treat HIV-1 positive patients, therefore robust drug-drug interaction data is required for medications that are prescribed with DTG.

Tuberculosis is biggest killer of patients that are co-infected with the HIV-1 virus, killing over 25% of the population. There is an unmet need for data concerning DTG once daily dosing in the presence of rifampicin (RIF), the widely used anti-tuberculosis antibiotic. This is the main purpose of this investigative study.

The design of the study is an open label, single site pharmacokinetic (PK) study to measure the blood plasma concentration of DTG in the presence of RIF.

The study will recruit 18-63 years old healthy volunteers, either male or non-pregnant females. Subjects will be recruited at the single study site. A site in the United Kingdom will be selected based on its past experience in the HIV field, and its ability to recruit 16 subjects from their healthy volunteer database.

The study period is expected to be 43 days, excluding screening and follow-up. The most significant procedures in terms of study data will be pharmacokinetic (PK) sampling days 7, 14, 35 and 42. On these days PK sampling will occur over a 24 hour period, mapping out the blood concentrations of DTG in the presence of RIF.

There will also be a pharmacogenomic sub-study included in the study design. Researchers have included this because the HIV investigator community agrees that a pharmacogenomic approach to HIV treatment is important to understand why patients show different degrees of virological responses or drug toxicity.

This research is funded by Wits Health Consortium, and sponsored by St Stephens Clinical Research. ;

Related Conditions & MeSH terms

• HIV-1-infection
• Tuberculosis

• NCT number: NCT03199690
• Study type: Interventional
• Source: St Stephens Aids Trust
• Contact: Project manager
• Phone: 0203 828 0593
• Email: radio@ststcr.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2017
• Completion date: March 2018