Developing new drugs for the treatment of drug-resistant tuberculosis: a regulatory perspective

Tuberculosis

Volumn 88, Issue SUPPL. 1, 2008, Pages

  Sacks, Leonard V ^a   Behrman, Rachel E ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Drug development; Multi drug resistant; tuberculosis

Indexed keywords

ANTIMYCOBACTERIAL AGENT; BACTERIAL DNA; CIPROFLOXACIN; DARUNAVIR; ENFUVIRTIDE; ETHAMBUTOL; ISONIAZID; MARAVIROC; NEW DRUG; PLACEBO; PROTEINASE INHIBITOR; PYRAZINAMIDE; QUINOLONE DERIVATIVE; RALTEGRAVIR; RIFAMPICIN; STREPTOMYCIN; TIPRANAVIR; TUBERCULOSTATIC AGENT;

ARTICLE; BACTERICIDAL ACTIVITY; BACTERIUM CULTURE; CLINICAL TRIAL; DRUG APPROVAL; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG SENSITIVITY; GENE EXPRESSION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MINIMUM INHIBITORY CONCENTRATION; MORTALITY; MULTIDRUG RESISTANCE; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PRIORITY JOURNAL; RELAPSE; SPUTUM CULTURE; TUBERCULOSIS;

ANIMALS; ANTITUBERCULAR AGENTS; CONTROLLED CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; HIV INFECTIONS; HUMANS; IMMUNOCOMPETENCE; RESEARCH DESIGN; TREATMENT OUTCOME; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 50449104247     PISSN: 14729792     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1472-9792(08)70040-4     Document Type: Article

References (38)

1. Fox W., Ellard G.A., and Mitchison D.A. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council Tuberculosis Units 1946-1986 with relevant subsequent publications?. Int J Tuberc Lung Dis 3 (1999) s231-s279
2. Gandhi N.R., Moll A., Sturm A.W., Pawinski R., Govender T., Lalloo U., Zeller K., and Andrews G.F. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa?. Lancet 368 (2006) 1575-1580
3. Moran J.S., and Bernard K.W. The spread of chloroquine-resistant malaria in Africa?. Implications for travelers JAMA 262 (1989) 245-258
4. Grant R.M., Hecht F.M., Warmerdam M., et al. Time trends in primary HIV-1 drug resistance among recently infected persons?. JAMA 288 (2002) 181-188
5. Chambers H. The changing epidemiology of Staphylococcus aureus?. Emerg Infect Dis 7 (2001) 178-182
6. Combs D.L., O'Brien R.J., and Geiter L.J. USPHS tuberculosis short-course chemotherapy trial 21: effectiveness, toxicity and acceptability?. Ann Intern Med 112 (1990) 397-406
7. Holtz T.H., Sternberg M., Kammerer S., Laserson K., Riedstina V., Zarovska E., Skripconoka V., Wells C.D., and Leimane V. Time to sputum culture conversion in multidrug resistant tuberculosis: Predictors and relationship to treatment outcome?. Ann Intern Med 144 (2006) 650-659
8. Goble M., Iseman M.D., Madsen L.A., Waite D., Ackerson L., and Horsburgh R. Treatment of 171 patients with pulmonary tuberculosis resistant to isoniazid and rifampin?. N Engl J Med 328 (1993) 527-532
9. Mitnick C., Bayona J., Palacios E., Shin S., Furin J., Alcantara F., Sanchez E., Sarria M., Ecerra M., Smith Fawz M.C., Kapiga S., Neuberg D., Maguire J.H., Kim J.Y., and Farmer P. Community-based therapy for multidrug-resistant tuberculosis in Lima, Peru?. N Engl J Med 348 (2003) 119-128
10. Park S.K., Kim C.T., and Song S.D. Outcome of chemotherapy in 107 patients with pulmonary tuberculosis resistant to isoniazid and rifampin?. Int J Tuberc Lung Dis 2 (1998) 877-884
11. Chan E.D., Laurel V., Strand M.J., Chan J.F., Huynh M.N., Goble M., and Iseman M.D. Treatment and outcome analysis of 205 patients with multidrug-resistant tuberculosis?. Am J Crit Care Med 169 (2004) 1103-1109
12. Yew W.W., Chan C.K., Chau C.H., Tam C.M., Wong P.C., and Lee J. Outcomes of patients with multidrug resistant pulmonary tuberculosis treated with ofloxacin/levofloxacin-containing regimens?. Chest 117 (2000) 744-751
13. Nathanson E., Lambregts-van Weezenbeek, Rich M.L., Gupta R., Bayona J., Blondal K., Caminero J.A., Cegielski J.P., Danilovits M., Espinal M.A., Hollo V., Jaramillo E., Leimane V., Mitnick C.D., Mukherjee J.S., Nunn P., Pasechnikov A., Tupasi T., Wells C., and Raviglione M.C. Multidrug-resistant tuberculosis, management in resource-limited settings?. Emerg Infect Dis 12 (2006) 1389-1397
14. Geerligs W.A., van Alten R., de Lange W.C.M., van Soolingen D., and van der Werf T.S. Multidrug-resistant tuberculosis: long-term treatment outcome in the Netherlands?. Int J Tuberc Lung Dis 4 (2000) 758-764
15. Singapore Tuberculosis service/British Medical Research Council. Clinical trial of six-month and four-month regimens of chemotherapy in the treatment of pulmonary tuberculosis?. Am Rev Respir Dis 119 (1979) 579-585
16. Singapore Tuberculosis service/British Medical Research Council. Assessment of a daily combined preparation of isoniazid, rifampin and pyrazinamide in a controlled trial of three 6-month regimens for smear-positive pulmonary tuberculosis?. Am Rev Respir Dis 143 (1991) 707-712
17. Mitchison D.A., and Nunn A.J. Influence of initial drug resistance on the response to short-course chemotherapy of pulmonary tuberculosis?. Am Rev Respir Dis 133 (1986) 423-430
18. Nitti V. Antituberculosis activity of rifampin. Report of studies performed and in progress (1966-1971)?. Chest 61 (1972) 589-598
19. Kennedy N., Berger L., Curram J., Fox R., Gutmann J., Kisyombe G.M., Ngowi F.I., Ramsay A., Saruni A., Sam N., Tillotson G., Uiso L.O., Yates M., and Gillespie S.H. Randomized controlled trial of a drug regimen that includes cipro-floxacin for the treatment of pulmonary tuberculosis?. Clin Infect Dis 22 (1996) 827-833
20. Aptivus package insert, Boehringer Ingelheim Pharmaceuticals Inc, 2007.
21. Prezista package insert, Tibotec Inc 2006.
22. Fuzeon package insert, Roche Laboratories Inc and Trimeris Inc 2007.
23. Sezentry package insert, Pfizer Inc 2007.
24. Isentress package insert, Merck &Co Inc 2007.
25. Mitchison D.A. Assessment of new sterilizing drugs for treatment of pulmonary tuberculosis by culture at 2 months?. Am Rev Respir Dis 147 (1993) 1062-1063
26. The tuberculosis trials consortium. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial?. Lancet 360 (2002) 528-534
27. Hernández-Pando R., Jeyanathan M., Mengistu G., Aguilar D., Orozco H., Harboe M., Rook G., and Bjune G. Persistence of DNA from Mycobacterium tuberculosis in superficially normal lung tissue during latent infection?. Lancet 356 (2000) 2133-2138
28. Mistry R., Cliff J.M., Clayton C.L., Beyers N., Mohamed Y.S., Wilson P.A., Dockrell H.M., Wallace D.W., van Helde P.D., Duncan K., and Lukey P.T. Gene-expression patterns in whole blood identify subjects at risk for recurrent tuberculosis?. J Infect Dis 195 (2007) 357-365
29. Centers for disease control and prevention. Treatment of Tuberculosis?. MMWR 52 RR11 (2003) 1-77
30. Sacks L.V., Pendle S., Orlovic D., Blumberg L., and Constantinou C. A comparison of outbreak-and non-outbreak-related multidrug-resistant tuberculosis among human immunodeficiency virus-infected patients in a South African hospital?. Clin Infect Dis 21 (1999) 96-101
31. Ritacco V., Di Leonard M., Reniero A., et al. Nosocomial spread of human immunodeficiency virus-related multi-drug resistant tuberculosis in Buenos Aires?. J Infect Dis 176 (1997) 637-642
32. Agerton T.B., Valway S.E., Blinkhorn R.J., Shilkret K.L., Reves R., Schluter W.W., Gore B., Pozsik C.J., Plikayatis B.B., Woodley C., and Onorato I.M. Spread of strain W, a highly drug-resistant strain of Mycobacterium tuberculosis, across the United States?. Clin Infect Dis 29 (1999) 85-92
33. Zignol M., Hosseini M.S., Wright A., Lambregts-vanWeezenbeek, Nunn P., Watt C.J., Williams G., and Dye C. Global incidence of multidrug-resistant tuberculosis?. J Infect Dis 194 (2006) 479-485
34. Moore D.A., Mendoza D., Gilman R.H., Evans C., Delgado M., Guerra J., Caviedes L., Vargas D., Ticona E., Ortiz J., Soto G., and Serpa J. Microscopic observation drug susceptibility assay a rapid reliable diagnostic test for multidrug resistant tuberculosis suitable for use in resource- poor settings?. J Clin Microbiol 42 (2004) 4432-4437
35. Hopewell P., Cynamon M., Starke J., Iseman M., and O'Brien R. Evaluation of new anti-infective drugs for the treatment and prevention of tuberculosis?. Clin Infect Dis 15 Suppl 1 (1992) s282-s295
36. Migliori G.B., Espinal M., Danilova I.D., Punga V.V., Grzemska M., and Raviglione M.C. Frequency of recurrence among MDR-TB cases "successfully" treated with standardized shortcourse chemotherapy?. Int J Tuberc Lung Dis 6 (2002) 858-864
37. Rieder H.K. Sputum smear conversion during directly observed treatment for tuberculosis?. Tubercle and Lung Disease 77 (1996) 124-129
38. 21 Code of Federal Regulations, Sec 314.500 and 314.510.