HivPhase 4DoRISNCT04166474
Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin
A Phase 4 study testing Dolutegravir in people with Hiv and Tuberculosis, run by Helen Reynolds at 2 sites in 2 countries.
Trial summary
This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Tuberculosis
- What is being tested?
- Dolutegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Nov 2021to 7 Feb 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent prior to participation
- Willing and able to comply with all study requirements
- Receiving standard doses of RIF and INH
- HIV antibody negative
- Male or non-pregnant, non-breastfeeding female
- Study participation will not extend length of ATT by more than 4 weeks
Who cannot join
- < 18 years
- Body weight < 50 kg
- eGFR < 60 mL/min
- Abnormal LFTs including ALT > 2.5 ULN
- HIV antibody positive
- Non-standard TB regimen (containing RHZE)
Show all 12Show fewer
- Women of childbearing age unless using effective contraception
- Family history of sudden cardiac death
- Prior history of cardiac disease that precludes the use of low dose digoxin
- Medical or psychiatric condition that might affect participation in the study based on investigator judgement
- Regular consumption of grapefruit or grapefruit juice
- ECG abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree AV block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
- Conditions
- Hiv, Tuberculosis
- Being tested
- Dolutegravir
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir | Experimental | Not described Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pharmacokinetic parameter Cmin of dolutegravir
Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin
Measured: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Secondary outcomes (3)
Change in pharmacokinetic parameter AUC of dolutegravir
Change in dolutegravir AUC when dosed with standard, medium, high dose rifampicin
Measured: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in pharmacokinetic parameter Cmax of dolutegravir
Change in dolutegravir Cmax when dosed with standard, medium, high dose rifampicin
Measured: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)
Measured: From first dose of dolutegravir until study completion approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start18 Nov 2021
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Reynolds
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Disease Institute, Kampala, Uganda, Desmond Tutu HIV Centre
- Responsible party
- Sponsor-investigator, Helen Reynolds, University of Liverpool
- Investigators
- Saye Khoo, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166474
- Sponsor's protocol ID
- UoL001452
- Acronym
- DoRIS
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2019
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin
- ClinicalTrials.gov ID
- NCT04166474
- Acronym / sponsor ID
- DoRIS / UoL001452
- Conditions
- Hiv, Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Helen ReynoldsUniversity, hospital or other
- Collaborators
- Infectious Disease Institute, Kampala, Uganda, Desmond Tutu HIV Centre
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 18 Nov 2019 (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.
This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir | Experimental | Drug: Dolutegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to give informed consent prior to participation
- Willing and able to comply with all study requirements
- Receiving standard doses of RIF and INH
- HIV antibody negative
- Male or non-pregnant, non-breastfeeding female
Key exclusion criteria (12 listed)
- < 18 years
- Body weight < 50 kg
- eGFR < 60 mL/min
- Abnormal LFTs including ALT > 2.5 ULN
- HIV antibody positive
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 |
|---|---|---|
| DolutegravirDosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin. | Drug | Dolutegravir |
Primary outcome
Change in pharmacokinetic parameter Cmin of dolutegravir
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin
3 secondary outcomes
Change in pharmacokinetic parameter AUC of dolutegravir
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in pharmacokinetic parameter Cmax of dolutegravir
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)
Time frame: From first dose of dolutegravir until study completion approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
Saye Khoo principal investigator
University of Liverpool
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir in people with Hiv and Tuberculosis, run by Helen Reynolds at 2 sites in 2 countries.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pharmacokinetic parameter Cmin of dolutegravir (time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment). 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 13 Aug 2024.