HIV Infections Clinical Trial
Official title:
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in the Treatment of Tuberculosis Patient With HIV Infection in Vietnam : A Phase II Trial
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | Pham Ngoc Tach Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Area under the curve (AUC) of lopinavir/ritonavir in combination with two doses of rifabutine | 5 and 8 weeks after randomisation | No | |
Secondary | Safety : proportion of patients with grade 3 and grade 4 adverse events | through out the trial | Yes |
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