NCT04166474CompletedPhase 4
Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin
Source: ClinicalTrials.gov · Last updated 13 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 1 Nov 2019
- Start date
- 18 Nov 2021
- Primary completion date
- 7 Feb 2024
- Lead sponsor
- Helen Reynolds
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04166474
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 36
- From 18 Nov 2021 to the primary completion date, 7 Feb 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of cardiac disease that precludes the use of low dose digoxin
Other illness
- HIV antibody positive
- Family history of sudden cardiac death
- Medical or psychiatric condition that might affect participation in the study based on investigator judgement
- 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)
Lab values
- eGFR \< 60 mL/min
- Abnormal LFTs including ALT \> 2.5 ULN
Age
- \< 18 years
- Women of childbearing age unless using effective contraception
Other
- Body weight \< 50 kg
- Non-standard TB regimen (containing RHZE)
- Regular consumption of grapefruit or grapefruit juice
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infectious Diseases Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.