NCT03731559CompletedPhase 2
Efficacy, Safety and Pharmacokinetics of DTG With RIF
Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 mg Once Daily With Food Versus Dolutegravir 50 mg Twice Daily in HIV/TB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV/TB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 31 Oct 2018
- Start date
- 25 Jun 2019
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Diseases
- HIV
- NCT number
- NCT03731559
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 123
- From 25 Jun 2019 to the primary completion date, 30 Jun 2025
- 10 sites in 1 country
- 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
- Have previously treated for tuberculosis
- Currently using immunosuppressive agents.
- Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine
- Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator
- Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug)
Other illness
- Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs
Lab values
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
Other
- Unlikely to be able to remain in the follow-up period as defined by the protocol
- Have Karnofsky performance score \<30%
- Pregnant or breastfeeding
Who the study is looking for
- documented HIV positive
- Aged \>18 years
- ARV naïve (previous exposure to ARV for \< 2 weeks)
- Any CD4 cell count
- ALT \<5 times ULN
- estimated GFR\>60 ml/min/1.73m2
- Hemoglobin \>7 mg/L
- TB is diagnosed and there is a plan to receive stable doses of RIF containing anti-TB therapy for at least another 4 week period after initiation of ART
- No other active OI (CDC class C event) except oral candidiasis or disseminated MAC
- Body weight \>40kg
- Able to provide written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klang Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| HIV-NAT/Thai Red Cross AIDS Research Centre Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Bhumibol Adulyadej Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chest Division, Faculty of Medicine, Chulalongkorn University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Infectious Disease Taksin Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Infectious Disease, Chulalongkorn University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Infectious Disease Chiangrai Prachanukroh Hospital Coordinator of this site? Confirm its status | Chiang Rai | Thailand | Unknown status |
| Infectious Disease Chonburi Hospital Coordinator of this site? Confirm its status | Chon Buri | Thailand | Unknown status |
| Bamrasnaradura Infectious Diseases Institute Coordinator of this site? Confirm its status | Nonthaburi | Thailand | Unknown status |
| Infectious Disease Buddhachinaraj Phitsanulok Hospital Coordinator of this site? Confirm its status | Phitsanulok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.