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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00651066
Other study ID # ANRS12150b
Secondary ID
Status Completed
Phase Phase 2
First received March 28, 2008
Last updated July 16, 2013
Start date June 2010
Est. completion date September 2012

Study information

Verified date July 2013
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Interventional

Clinical Trial 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.


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 will be then adapted to the allocated RBT regimen according to a cross over scheme. Three full pharmacokinetics profile will be performed at different time point : before initiation of ARV, after three weeks of the first RBT dosage and after three weeks of the secondRBT dosage. Patients will then be referred to the national program for further treatment. A follow-up visit will be planned at the end of the antiTB treatment.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1
3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg TPW 3 wks switch to 150 mg OD 4 wks);
rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);

Locations

Country Name City State
Vietnam Pham Ngoc Tach Hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

Vietnam, 

Outcome

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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