Actively Recruiting
Efficacy, Safety and Pharmacokinetics of DTG with RIF
Led by The HIV Netherlands Australia Thailand Research Collaboration · Updated on 2024-10-02
200
Participants Needed
10
Research Sites
313 weeks
Total Duration
On this page
Sponsors
T
The HIV Netherlands Australia Thailand Research Collaboration
Lead Sponsor
C
Chulalongkorn University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Efficacy, Safety and Pharmacokinetics of DTG with RIF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV positive
- Aged over 18 years
- Antiretroviral therapy naive or previous exposure less than 2 weeks
- Any CD4 cell count
- ALT less than 5 times the upper limit of normal
- Estimated glomerular filtration rate greater than 60 ml/min/1.73m2
- Hemoglobin greater than 7 mg/L
- Diagnosed tuberculosis with plan to receive stable rifampin-containing anti-TB therapy for at least 4 weeks after starting ART
- No other active opportunistic infections except oral candidiasis or disseminated MAC
- Body weight over 40 kg
- Able to provide written informed consent
You will not qualify if you...
- History of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or integrase inhibitors
- Previous tuberculosis treatment
- Current use of immunosuppressive agents
- Current use of prohibited medications affecting study drug pharmacokinetics such as phenobarbital and carbamazepine
- Current use of alcohol or illicit substances affecting trial participation as judged by the investigator
- Unlikely to complete follow-up as required by the protocol
- Proven or suspected acute hepatitis; chronic viral hepatitis allowed if ALT and AST less than 5 times upper limit of normal
- Karnofsky performance score less than 30%
- Tuberculosis meningitis or bone/joint tuberculosis
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Klang Hospital
Bangkok, Bangkok, Thailand, 10100
Actively Recruiting
2
Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand, 10220
Actively Recruiting
3
Infectious Disease, Chulalongkorn University
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
4
Infectious Disease Taksin Hospital
Bangkok, Bangkok, Thailand, 10600
Actively Recruiting
5
Infectious Disease Chonburi Hospital
Chon Buri, Changwat Chon Buri, Thailand, 20000
Actively Recruiting
6
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, Thailand, 11000
Actively Recruiting
7
Infectious Disease Buddhachinaraj Phitsanulok Hospital
Phitsanulok, Changwat Phitsanulok, Thailand, 65000
Actively Recruiting
8
Infectious Disease Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, Thailand, 57000
Actively Recruiting
9
Chest Division, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
10
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Thailand, 10330
Actively Recruiting
Research Team
J
June Ohata, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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