Efficacy, Safety and Pharmacokinetics of DTG with RIF
Recruiting · NCT03731559 · Interventional (participants receive a specific treatment) · Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
View the official record on ClinicalTrials.gov →Interventions studied
DTG 50 mg BIDDTG 50 mg OD with food
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs
- 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
- Unlikely to be able to remain in the follow-up period as defined by the protocol
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
- Have Karnofsky performance score \<30%
- Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug)
- Pregnant or breastfeeding
Where it is running
10 locations listed.
- Chest Division, Faculty of Medicine, Chulalongkorn University - Bangkok, Thailand
- HIV-NAT, Thai Red Cross - AIDS Research Centre - Bangkok, Thailand
- Klang Hospital - Bangkok, Bangkok, Thailand
- Bhumibol Adulyadej Hospital - Bangkok, Bangkok, Thailand
- Infectious Disease, Chulalongkorn University - Bangkok, Bangkok, Thailand
- Infectious Disease Taksin Hospital - Bangkok, Bangkok, Thailand
- Infectious Disease Chonburi Hospital - Chon Buri, Changwat Chon Buri, Thailand
- Bamrasnaradura Infectious Diseases Institute - Nonthaburi, Changwat Nonthaburi, Thailand
- Infectious Disease Buddhachinaraj Phitsanulok Hospital - Phitsanulok, Changwat Phitsanulok, Thailand
- Infectious Disease Chiangrai Prachanukroh Hospital - Chiang Rai, Chiangrai, Thailand