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Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in HIV

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection; Tuberculosis

Intervention: Lopinavir/Ritonavir (Drug); Lopinavir/Ritonavir (Drug); Raltegravir (Drug); Isoniazid (Drug); Pyridoxine (Drug); Pyrazinamide (Drug); Ethambutol (Drug); Rifabutin (Drug); Rifampin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Constance A Benson, MD, Study Chair, Affiliation: University of California, San Diego
Umesh Lalloo, MD, FRCP, Study Chair, Affiliation: Nelson R. Mandela School of Medicine

Summary

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor-based antiretroviral therapy. This study will compare three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a protease inhibitor together with rifabutin-based anti-TB treatment. Accrual will take place in two accrual periods. Accrual period 1 will enroll 60 participants who will undergo an initial dose-finding period before continuing regular study follow-up. Once the review of the dose-finding pharmacokinetic and safety data from accrual period 1 participants is completed, accrual period 2 will begin.

Clinical Details

Official title: A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifampin-Based Tuberculosis Treatment Versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifabutin-Based Tuberculosis Treatment With or Without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent of participants whose HIV viral load was less than 400 copies/mL (Arm B vs Arm A and Arm B vs Arm C)

Secondary outcome:

Percent of participants who experienced mycobacterial culture conversion (Arm B vs Arm A and Arm B vs Arm C)

Percent of participants who experienced TB treatment failure (Arm B vs Arm A and Arm B vs Arm C)

Percent of participants who experienced TB relapse/recurrence (Arm B vs Arm A and Arm B vs Arm C)

Percent of participants whose HIV viral load was less than 50 copies/mL (Arm B vs Arm A and Arm B vs Arm C)

Percent of participants whose HIV viral load was less than 400 copies/mL (Arm A vs Arm C)

Percent of participants whose HIV viral load was less than 50 copies/mL (Arm A vs Arm C)

Percent of participants reporting a grade 3 or 4 adverse event or laboratory abnormality recurrence

Percent of participants who interrupted or discontinued at least one HIV drug due to toxicity

Percent of participants who interrupted or discontinued at least one TB drug due to toxicity

Percent of participants who experienced HIV virologic failure

Percent of participants who experienced TB IRIS

CD4 count change from randomization

Percent of participants who experienced a new AIDS-defining illness

Percent of participants who experienced death

Percent of participants who experienced a new AIDS-defining illness or death

Time to HIV virologic failure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV-1 infection

- CD4+/CD8+ T-cell count obtained within 30 days prior to study entry

- Confirmed or probable pulmonary or extrapulmonary TB (more information on the

criterion can be found in the protocol)

- Chest x-ray within 30 days prior to study entry.

- A PI-based antiretroviral (ART) regimen is required, as determined by the

participant's primary clinician/clinical facility.

- Certain laboratory values obtained within 14 days prior to study entry (more

information on the criterion can be found in the protocol)

- For females of reproductive potential, negative serum or urine pregnancy test within

7 days prior to study entry and 72 hours of starting study medications.

- Willing to use acceptable methods of contraception while on study drugs and for 6

weeks after stopping these drugs.

- Karnofsky performance score > 40 within 14 days prior to study entry, and likelihood

of survival, in the opinion of the site investigator, for at least 6 months.

- Ability to swallow oral medications.

- Ability and willingness of participant or legal guardian/representative to provide

informed consent. Exclusion Criteria:

- History of completed TB treatment and resolution of TB symptoms less than 1 year

prior to the current TB episode at study entry, or incomplete treatment for a prior episode of TB (i. e., defaulted past TB treatment) at any time prior to the current TB episode.

- Documented multidrug-resistant tuberculosis (MDR TB) or extensively drug-resistant

(XDR) TB.

- Participants infected with a rifamycin resistant strain of TB (more information on

the criterion can be found in the protocol).

- Receipt of more than 28 cumulative days of anti-TB treatment for the current TB

episode prior to study entry.

- Active drug or alcohol use or dependence that, in the opinion of the site

investigator, would interfere with adherence to study requirements.

- Active illness requiring systemic treatment and/or hospitalization within 30 days

prior to study entry, or that in the opinion of the site investigator, might otherwise interfere with adherence to study requirements.

- Pregnant or breastfeeding.

- Anticipated receipt of prohibited medications (more information on the criterion can

be found in the protocol).

- Known intolerance/allergy/sensitivity or any hypersensitivity to components of study

drugs or their formulations.

- History of close contact with known MDR or XDR TB patients at any time prior to study

entry.

Locations and Contacts

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro 21045, Brazil; Recruiting
Sandra W. Cardoso, Phone: 552-125-644933, Email: sandra.wagner@bol.com.br
Beatriz Grinsztejn, MD, PhD, Principal Investigator

Wits HIV CRS (11101), Johannesburg, Gauteng, South Africa; Recruiting
Paulina Vunandlala, Phone: 27-11-2768800, Email: pvunandlala@witshealth.co.za
Prudence Ive, FCP, Principal Investigator

Additional Information

Starting date: April 2013
Last updated: August 5, 2015

Page last updated: August 23, 2015

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