Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam
1 other identifier
interventional
47
1 country
1
Brief Summary
The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 17, 2013
July 1, 2013
2.3 years
March 28, 2008
July 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC) of rifabutine measured (a)before introduction of ART;(b)after ART initiation (two different doses of RBT in combination with lopinavir/ritonavir)
2, 5 and 8 weeks after randomisation
Secondary Outcomes (2)
Area under the curve (AUC) of lopinavir/ritonavir in combination with two doses of rifabutine
5 and 8 weeks after randomisation
Safety : proportion of patients with grade 3 and grade 4 adverse events
through out the trial
Study Arms (2)
1
EXPERIMENTALRBT (150 mg TPW during 3 weeks switch to 150mg OD for the following 3 weeks) associated with LPV/r based ART
2
EXPERIMENTALRBT (150 mg OD during 3 weeks switch to 150mg TPW for the following 3 weeks) associated with LPV/r based ART
Interventions
3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg TPW 3 wks switch to 150 mg OD 4 wks);
3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);
Eligibility Criteria
You may qualify if:
- Pulmonary tuberculosis defined as either
- at least 2 sputum smears positive for AFB
- sputum smear positive for AFB and a chest radiograph compatible with active tuberculosis
- sputum culture positive and and a chest radiograph compatible with active tuberculosis
- a clinical history and chest radiograph compatible with active tuberculosis and 2 sputum smear negative for AFB
- Positive HIV antibody and CD4 count \<=250 /mm3
- Weight \> 40 kg
- No history of ART
- No grade 3 or 4 clinical or laboratory findings
- Negative pregnancy test and appropriate contraceptive measures during the duration of the trial for female of childbearing age
- Having a firm home address that is readily accessible
- Karnofsky score\>=80%
You may not qualify if:
- History of TB or MDR TB treatment
- Concomitant OI requiring additional anti-infectious treatment
- Formal contraindication to any drug used in the trial
- Diabetes mellitus requiring drug treatment
- Recreational drug or alcohol abuse
- History of drug hypersensitivity to TB or related medications
- Interrupted TB therapy for more than 1 week
- Less than 90% adherent to first 6 weeks of intensive phase chemotherapy
- Mental illness that could impair ability to give informed consent or result in poor adherence to trial protocol and therapy
- Neutropenia \<1200 /L, anaemia \<6.8 g/dL, liver function test \> grade 2
- Requiring concomitant medications that may potentially interact with study drugs
- Pregnant or lactating women
- Karnofsky score \>80%
- Any condition rendering the patient unable to understand the nature, scope, and possible consequences of thes study and to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pham Ngoc Tach Hospital
Ho Chi Minh City, Vietnam
Related Publications (1)
Lan NT, Thu NT, Barrail-Tran A, Duc NH, Lan NN, Laureillard D, Lien TT, Borand L, Quillet C, Connolly C, Lagarde D, Pym A, Lienhardt C, Dung NH, Taburet AM, Harries AD. Randomised pharmacokinetic trial of rifabutin with lopinavir/ritonavir-antiretroviral therapy in patients with HIV-associated tuberculosis in Vietnam. PLoS One. 2014 Jan 22;9(1):e84866. doi: 10.1371/journal.pone.0084866. eCollection 2014.
PMID: 24465443DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony D. Harries, PhD
The international Union Against Tuberculosis and Lung Diseases (IUATLD), Paris, France
- PRINCIPAL INVESTIGATOR
Huy Dung Nguyen, MD
Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 2, 2008
Study Start
June 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 17, 2013
Record last verified: 2013-07