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HIV InfectionsPhase 2NCT00651066

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam

A Phase 2 study testing rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1 and rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2 in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Tuberculosis
What is being tested?
rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1 and rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteVietnam
Study dates
Jun 2010to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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%

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Pham Ngoc Tach Hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

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.

Read the 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 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.

Being tested
rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1, rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
Keywords
HIV, Tuberculosis, Rifabutin, Pharmacokinetics, Vietnam
Medical subject headings
HIV Infections, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1Drug

    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 2Drug

    3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);

Study groups in NCT00651066
Study groupRoleWhat they receive
1ExperimentalRBT (150 mg TPW during 3 weeks switch to 150mg OD for the following 3 weeks) associated with LPV/r based ART
Receives: Drug: rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1
2ExperimentalRBT (150 mg OD during 3 weeks switch to 150mg TPW for the following 3 weeks) associated with LPV/r based ART
Receives: Drug: rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2, 5 and 8 weeks after randomisation

Secondary outcomes (2)

  1. Area under the curve (AUC) of lopinavir/ritonavir in combination with two doses of rifabutine

    Measured: 5 and 8 weeks after randomisation

  2. Safety : proportion of patients with grade 3 and grade 4 adverse events

    Measured: through out the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2008 (estimated)
  2. Study startJun 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00651066
Sponsor's protocol ID
ANRS12150b
Status last verified
Jul 2013
First submitted
28 Mar 2008
Last updated
17 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24465443

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1 and rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2 in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 2, 5 and 8 weeks after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00651066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.

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