HIV-1-infectionPhase 1RADIONCT03199690
A Clinical Study Investigating Rifampicin and Dolutegravir in Combination in Healthy Volunteers
A Phase 1 study testing Dolutegravir and Rifampicin in people with HIV-1-infection and Tuberculosis, run by St. Stephens Clinical Research.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Tuberculosis
- What is being tested?
- Dolutegravir and Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Male or non-pregnant, non-lactating females.
- Between 18 to 60 years, inclusive
- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive (with weight ≥50kg).
- Alanine aminotransferase, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
- Women of childbearing potential (WOCBP - definition in Appendix 4) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 3 months after the study.
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- A female may be eligible to enter and participate in the study if she:
- is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
- True abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 4 weeks after discontinuation of all study medications. (When this is in line with the preferred and usual lifestyle of the subject.) (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception].
- Any non-hormonal intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see protocol appendix 4 for an example listing of approved IUDs);
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject; Any contraception method must be used consistently, in accordance with the approved product label and for at least 4 weeks after discontinuation of IP.
- Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 4 must be using an adequate method of contraception to avoid pregnancy in their partner throughout the study and for a period of at least 4 weeks after the study (see inclusion criteria 6);
- True abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 4 weeks after discontinuation of all study medications (When this is in line with the preferred and usual lifestyle of the subject.) (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception].
- Any non-hormonal intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 4 for an example listing of approved IUDs);
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject; Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP.
- Willing to consent to their personal details being entered onto the TOPS database
- Willing to provide proof of identity by photographic ID at screen and any subsequent visit
- Registered with a GP in the UK
Who cannot join
- Any clinically significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Positive blood screen for hepatitis B surface antigen or C antibody
- Positive blood screen for HIV-1 or 2 by antibody/antigen assay
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Current or recent (within three months) gastrointestinal disease.
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- Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
- Exposure to any investigational drug (or placebo) or participation in a clinical study involving the donation of blood samples within three months of first dose of study drug
- Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
- Females of childbearing potential without the use of effective birth control methods, or not willing to continue practising these birth control methods for at least 4 weeks after the end of the treatment period.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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.
- Conditions
- HIV-1-infection, Tuberculosis
- Being tested
- Dolutegravir, Rifampicin
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Also called Tivicay
Antiviral (integrase inhibitor)
RifampicinDrug
Also called Rifidan
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 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 Receives: Drug: Dolutegravir; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Ctrough is defined as the concentration at 24 hours after the observed drug dose.
Measured: 43 days
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)
Maximum observed plasma concentration (Cmax).
Measured: 43 days
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)
Elimination half-life (t1/2)
Measured: 43 days
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 point at Cmax (Tmax)
Measured: 43 days
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.
Total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startOct 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- open label, single centre, sequential pharmacokinetic study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Stephens Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199690
- Sponsor's protocol ID
- SSCR103
- Acronym
- RADIO
- Status last verified
- Oct 2017
- First submitted
- 20 Jun 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03199690
- Acronym / sponsor ID
- RADIO / SSCR103
- Conditions
- HIV-1-infection, Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- St. Stephens Clinical ResearchUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label, single centre, sequential pharmacokinetic study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Dolutegravir, Drug: RifampicinSingle 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Male or non-pregnant, non-lactating females.
- Between 18 to 60 years, inclusive
- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive (with weight ≥50kg).
- Alanine aminotransferase, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
Key exclusion criteria (10 listed)
- Any clinically significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Positive blood screen for hepatitis B surface antigen or C antibody
- Positive blood screen for HIV-1 or 2 by antibody/antigen assay
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DolutegravirAlso: TivicayAntiviral (integrase inhibitor) | Drug | Single arm |
| RifampicinAlso: RifidanAntibiotic | Drug | Single arm |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dolutegravir and Rifampicin in people with HIV-1-infection and Tuberculosis, run by St. Stephens Clinical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Project manager (0203 828 0593, radio@ststcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.