NCT02415985

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 hiv

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_2 hiv

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

April 1, 2015

Last Update Submit

February 11, 2020

Conditions

HIVTuberculosis

Keywords

pharmacokinetics of rifabutinHIV/TB co-infectionresource limited settingAUCCmaxCminCtrough

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics of rifabutin Cmax

    Cmax The peak plasma concentration of rifabutin after administration

    48 weeks

Secondary Outcomes (14)

  • adverse events

    48 weeks

  • viral load

    48 weeks

  • CD4

    48 weeks

  • Monodrug resistant TB

    48 weeks

  • death

    48 weeks

  • +9 more secondary outcomes

Study Arms (2)

rifabutin 150

OTHER

rifabutin 150 mg (1 capsule) once daily

Drug: Lopinavir/r will be supplied by NHSO/GPODrug: Rifabutin

rifabutin 300

OTHER

rifabutin 150 mg (2 capsules) 300 mg 3 times a week

Drug: Lopinavir/r will be supplied by NHSO/GPODrug: Rifabutin

Interventions

Lopinavir/r will be supplied by NHSO/GPODRUG

200/50 mg tablet LPV/rtv

Also known as: LPV/rtv
rifabutin 150rifabutin 300
RifabutinDRUG
rifabutin 150rifabutin 300

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chest Division, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, 10330, Thailand

Location

Infectious Diseases, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Location

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

Rifabutin

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Anchalee Avihingsanon, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 14, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

TH(4)