Status:
COMPLETED
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Detailed Description
Patients will be offered to participated in the study when they start TB treatment. All the enrolled patients will immediately be switched to rifabutin and randomized, to one of the RBT doses that wil...
Eligibility Criteria
Inclusion
- Pulmonary tuberculosis defined as either
- at least 2 sputum smears positive for AFB
- 1 sputum smear positive for AFB and a chest radiograph compatible with active tuberculosis
- 1 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%
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00651066
Start Date
June 1 2010
End Date
September 1 2012
Last Update
July 17 2013
Active Locations (1)
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1
Pham Ngoc Tach Hospital
Ho Chi Minh City, Vietnam