A Clinical Study Investigating Rifampicin and Dolutegravir in Combination in Healthy Volunteers (RADIO)
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|ClinicalTrials.gov Identifier: NCT03199690|
Recruitment Status : Unknown
Verified October 2017 by St Stephens Aids Trust ( St. Stephens Clinical Research ).
Recruitment status was: Not yet recruiting
First Posted : June 27, 2017
Last Update Posted : October 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection Tuberculosis||Drug: Dolutegravir Drug: Rifampicin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||open label, single centre, sequential pharmacokinetic study|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Single arm
Single arm trial design based on the dosing regimen below:
Day 1 - 7
- Dolutegravir 50 mg once daily with food
Day 8 - 14 - Dolutegravir 100 mg once daily with food
Day 15 - 28
- Rifampicin 600 mg once daily
Day 29 - 35 - Rifampicin 600 mg once daily & Dolutegravir 50 mg once daily
Day 36 - 42
- Rifampicin 600 mg once daily & Dolutegravir 100 mg once daily
Antiviral (integrase inhibitor)
Other Name: Tivicay
Other Name: Rifidan
- To investigate the pharmacokinetics of DTG 50 or 100 mg OD in the presence of RIF 600 mg OD in healthy volunteers as measured by trough concentration (Ctrough) [ Time Frame: 43 days ]Ctrough is defined as the concentration at 24 hours after the observed drug dose.
- To investigate the pharmacokinetics of DTG 50 or 100 mg OD in the presence of RIF 600 mg OD in healthy volunteers as measured by maximum observed plasma concentration (Cmax) [ Time Frame: 43 days ]Maximum observed plasma concentration (Cmax).
- To investigate the pharmacokinetics of DTG 50 or 100 mg OD in the presence of RIF 600 mg OD in healthy volunteers as measured by elimination half-life (t1/2) [ Time Frame: 43 days ]Elimination half-life (t1/2)
- To investigate the pharmacokinetics of DTG 50 or 100 mg OD in the presence of RIF 600 mg OD in healthy volunteers as measured by time point at Cmax (Tmax) [ Time Frame: 43 days ]Time point at Cmax (Tmax)
- To investigate the pharmacokinetics of DTG 50 or 100 mg OD in the presence of RIF 600 mg OD in healthy volunteers as measured by total drug exposure. [ Time Frame: 43 days ]Total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199690
|Contact: Project manager||0203 828 firstname.lastname@example.org|