Efficacy, Safety and Pharmacokinetics of DTG With RIF

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Bamrasnaradura Infectious Diseases Institute; Bhumibol Adulyadej Hospital; Chest Division, Chulalongkorn University; Department of Disease Control, Ministry of Public Health (MOPH), Thailand; Infectious Disease Buddhachinaraj Phitsanulok Hospital; Infectious Disease Chiangrai Prachanukroh Hospital; Infectious Disease Chonburi Hospital; Infectious Disease Taksin Hospital; Infectious Disease, Chulalongkorn University; Klang Hospital; Radboud UMC Nijmegen, The Netherlands
• Treatments: Antitubercular Agents; Dolutegravir; Rifampin

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 containing anti-TB therapy for at least another 4 week period after initiation of ART

9. No other active OI (CDC class C event) except oral candidiasis or disseminated MAC

10. Body weight >40kg

11. Able to provide written informed consent

Exclusion Criteria:

1. Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs

2. Have previously treated for tuberculosis

3. Currently using immunosuppressive agents.

4. Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine

5. Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator

6. Unlikely to be able to remain in the follow-up period as defined by the protocol

7. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.

8. Have Karnofsky performance score <30%

9. Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug)

10. Pregnant or breastfeeding