Status:
COMPLETED
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa
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 after the first 6 weeks of the nationally recommended TB treatment. All the enrolled patients will be switched to rifabutin and randomized, two we...
Eligibility Criteria
Inclusion
- Pulmonary tuberculosis (proven by AFB positive sputum or culture)
- Having completed and adhered to 6 wks of intensive phase TB chemotherapy
- Positive HIV antibody and CD4 count \>50 /mm3 and \<=200
- Weight \> 50 kg
- No ART in the preceding 3 months
- No more than 2 weeks or ART previously
- 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 within the 3 years preceding the presenting episode of TB
- Previous treatment for MDR TB
- 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 :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00640887
Start Date
February 1 2009
End Date
October 1 2010
Last Update
June 20 2011
Active Locations (1)
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1
Unit for Clinical and Biomedical TB Research (Medical Research Council)
Durban, South Africa, 4067