Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02415985
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Public title: Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly
• Scientific title: A Pilot Study of the Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly With Lopinavir/Ritonavir Based HAART in HIV/TB Co-infected Patients
• Date of first enrolment: June 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415985
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Anchalee Avihingsanon, MD, PhD
• Affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Confirmed HIV positive after voluntary counseling and testing

2. Aged >18-60years of age

3. PI-naïve (NNRTI intolerance/failure) or PI experience ( TB developed during on salvage
regimen) without prior PI mutation

4. Any CD4 cell count

5. ALT <5 times ULN

6. Serum creatinine <1.4 mg/dl

7. Hemaglobin >7 mg/L

8. TB is diagnosed and planned to receive stable doses of rifabutin 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. Current use of steroid (except short course steroid for IRIS) and other
immunosuppressive agents.

2. Current use of any prohibited medications related to drug pharmacokinetics.

3. Patients with current alcohol or illicit substance use that in the opinion of the site
Principal Investigator would conflict with any aspect of the conduct of the trial.

4. Unlikely to be able to remain in follow-up for the protocol defined period.

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

6. Karnofsky performance score <30%

7. TB meningitis and bone/joints ( due to longer period of anti TB drug)

8. Pregnancy

9. Patient choose to use efavirenz, not LPV/r. However, in ART naïve, EFV is allowed
after intensive PK of LPV/r and rifabutin at week 2-4.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

HIV

Intervention(s)

Drug: Lopinavir/r will be supplied by NHSO/GPO

Drug: Rifabutin

Primary Outcome(s)

pharmacokinetics of rifabutin Cmax [Time Frame: 48 weeks]

Secondary Outcome(s)

CD4 [Time Frame: 48 weeks]

TB relapse [Time Frame: 48 weeks]

TB treatment failure [Time Frame: 48 weeks]

AIDS event [Time Frame: 48 weeks]

death [Time Frame: 48 weeks]

Karnofsky score [Time Frame: 48 weeks]

weight gain [Time Frame: 48 weeks]

Extensively drug resistant TB (XDR TB) [Time Frame: 48 weeks]

viral load [Time Frame: 48 weeks]

Monodrug resistant TB [Time Frame: 48 weeks]

TB cure [Time Frame: 48 weeks]

adverse events [Time Frame: 48 weeks]

defervescence [Time Frame: 48 weeks]

Multidrug-resistant TB (MDR TB) [Time Frame: 48 weeks]

Secondary ID(s)

HIV-NAT 116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chulalongkorn University

Bamrasnaradura Infectious Diseases Institute