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Tests treatment safety and results for HIV/TB Coinfection
Official title Efficacy, Safety and Pharmacokinetics of DTG with RIF
ClinicalTrials.gov ID: NCT03731559
What this study is testing
What is DTG 50 mg OD with food?
DTG 50 mg OD with food is an investigational medicine, given as an once-daily, being studied as a potential treatment for hiv/tb coinfection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- documented HIV positive
- Aged \>18 years
- ARV naïve (previous exposure to ARV for \< 2 weeks)
- Any CD4 cell count
- ALT \<5 times ULN
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Bangkok, Thailand
- Chon Buri, Changwat Chon Buri, Thailand
- Nonthaburi, Changwat Nonthaburi, Thailand
- Phitsanulok, Changwat Phitsanulok, Thailand
- Chiang Rai, Chiangrai, Thailand
- Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Bangkok, Thailand; Chon Buri, Changwat Chon Buri, Thailand; Nonthaburi, Changwat Nonthaburi, Thailand; Phitsanulok, Changwat Phitsanulok, Thailand; Chiang Rai, Chiangrai, Thailand; Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.