Rifampin and Recurrence of Tuberculosis among Patients Infected with HIV

Lambert, Marie‐Laurence; Hasker, Epco; Deun, Armand Van; Roberfroid, Dominique; Stuyft, Patrick Van der

doi:10.1086/379616

Cited by 11 publications

(2 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Relapse and reinfection disease can only be reliably distinguished if molecular typing of strains from the 2 episodes is available. In the absence of paired DNA fingerprints, the timing of the recurrence can give clues to the likely cause, because relapses generally occur soon after the end of treatment, whereas reinfection disease occurs at a more constant rate over time [10][11][12].…”

mentioning

confidence: 99%

High Rates of Recurrence in HIV‐Infected and HIV‐Uninfected Patients with Tuberculosis

Glynn

Murray

Bester³

et al. 2010

J INFECT DIS

View full text Add to dashboard Cite

Background. The rate of recurrent tuberculosis disease due to reinfection, compared with the incidence of new tuberculosis, in those with and without HIV infection is not known.Methods. In a retrospective cohort study of South African gold miners, men with known dates of seroconversion to HIV (from 1991 to 1997) and HIV-negative men were followed up to 2004. Rates of tuberculosis recurrence 12 years after the first episode were used as a proxy for reinfection disease rates.Results. Among 342 HIV-positive and 321 HIV-negative men who had had у1 previous episode of tuberculosis, rates of recurrence were 19.7 cases per 100 person-years at risk (PYAR; 95% confidence interval [CI], 16.4-23.7) and 7.7 cases per 100 PYAR (95% CI, 6.1-9.8), respectively. The recurrence rate did not vary by duration of HIV infection. Recurrent pulmonary tuberculosis rates 12 years after the first episode were 24.4 cases per 100 PYAR (95% CI, 17.2-34.8) in HIV-positive men and 4.3 cases per 100 PYAR (95% CI, 2.2-8.3) in HIV-negative men, compared with incidence rates of new pulmonary tuberculosis of 3.7 cases per 100 PYAR (95% CI, 3.3-4.1) in HIV-positive men and 0.75 cases per 100 PYAR (95% CI, 0.67-0.84) in HIV-negative men in the same cohort.Conclusions. Tuberculosis recurrence rates, likely due to reinfection, were much higher than incidence rates. The findings suggest heterogeneity in susceptibility, implying that a vaccine could still provide useful protection in the population and strengthening the case for secondary preventive therapy.

show abstract

mentioning

confidence: 99%

High Rates of Recurrence in HIV‐Infected and HIV‐Uninfected Patients with Tuberculosis

Glynn

Murray

Bester³

et al. 2010

J INFECT DIS

View full text Add to dashboard Cite

show abstract

“…An effective regimen should be able to prevent relapse but have no effect on re-infection. In a context of a significant burden of both TB and HIV, such as in our site in Durban, the proportion of recurrences due to re-infection can be high [19,20]. Even if these will be balanced across arms in a randomized trial, they could dilute the real regimen effect which is primarily assessed by relapses.…”

Section: Results and Discussion Of Methodological Issuesmentioning

confidence: 99%

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

Merle

Sismanidis

et al. 2012

Trials

View full text Add to dashboard Cite

BackgroundThere have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation?MethodsVarious drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385).ResultsIn the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements.ConclusionWhen shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection.

show abstract

Bacillus Calmette-Gu�rin shares with virulent the capacity to subvert monocyte differentiation into dendritic cell: implication for its efficacy as a vaccine preventing tuberculosis

Gagliardi

Teloni

Mariotti

et al. 2004

Vaccine

View full text Add to dashboard Cite

Rifampin and Recurrence of Tuberculosis among Patients Infected with HIV

Cited by 11 publications

References 8 publications

High Rates of Recurrence in HIV‐Infected and HIV‐Uninfected Patients with Tuberculosis

High Rates of Recurrence in HIV‐Infected and HIV‐Uninfected Patients with Tuberculosis

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

Bacillus Calmette-Gu�rin shares with virulent the capacity to subvert monocyte differentiation into dendritic cell: implication for its efficacy as a vaccine preventing tuberculosis

Contact Info

Product

Resources

About