Efficacy, Safety and Pharmacokinetics of DTG with RIF
Recruiting
Phase 2
Interventional Study
HIV/TB Coinfection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. documented HIV positive
2. Aged \>18 years
3. ARV naïve (previous exposure to ARV for \< 2 weeks)
4. Any CD4 cell count
5. ALT \<5 times ULN
6. estimated GFR\>60 ml/min/1.73m2
7. Hemoglobin \>7 mg/L
8. TB is diagnosed and there is a plan to receive stable doses of RIF contain…
Contacts