Pharmacokinetics and Safety of Rifabutin 150 mg Once Dail... | NCT02415985

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

NCT02415985

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Last Update Posted

Feb 12, 2020Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

HIV
Tuberculosis

Interventions

Lopinavir/r will be supplied by NHSO/GPO
Rifabutin

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Apr 1, 2015

First Submission Date that Met QC Criteria

Apr 13, 2015

First Posted Date

Apr 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2020

Last Update Posted Date

Feb 12, 2020Actual

Name	Class
Bamrasnaradura Infectious Diseases Institute	OTHER_GOV
Chulalongkorn University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients

Detailed Description

The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative to rifampicin for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated ART drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rifabutin 150	Other	rifabutin 150 mg (1 capsule) once daily	Drug: Lopinavir/r will be supplied by NHSO/GPO Drug: Rifabutin
rifabutin 300	Other	rifabutin 150 mg (2 capsules) 300 mg 3 times a week	Drug: Lopinavir/r will be supplied by NHSO/GPO Drug: Rifabutin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lopinavir/r will be supplied by NHSO/GPO	Drug	200/50 mg tablet LPV/rtv	rifabutin 150 rifabutin 300

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pharmacokinetics of rifabutin Cmax	Cmax The peak plasma concentration of rifabutin after administration	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
adverse events	number of participants with adverse events	48 weeks
viral load		48 weeks
CD4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed HIV positive after voluntary counseling and testing
Aged >18-60years of age
PI-naïve (NNRTI intolerance/failure) or PI experience ( TB developed during on salvage regimen) without prior PI mutation
Any CD4 cell count
ALT <5 times ULN
Serum creatinine <1.4 mg/dl
Hemaglobin >7 mg/L
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
No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
Body weight >40kg
Able to provide written informed consent

Exclusion Criteria:

Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
Current use of any prohibited medications related to drug pharmacokinetics.
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.
Unlikely to be able to remain in follow-up for the protocol defined period.
Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.
Karnofsky performance score <30%
TB meningitis and bone/joints ( due to longer period of anti TB drug)
Pregnancy
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anchalee Avihingsanon, MD, PhD	Thai Red Cross AIDS Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chest Division, Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand
HIV-NAT, Thai Red Cross - AIDS Research Centre

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds