Table 1.

Phase 2 Clinical Trial Results With Fluoroquinolone-containing Regimens

Reference of Clinical Trial and Study Period		Number and Location of Clinical Sites	Number of Subjects Enrolled/Analyzed	Proportion of HIV Infected Subjects	Regimen	Outcome	P (vs Control)
Phase 2a	Gosling et al [18] 2003	1 site in Tanzania	43 enrolled/32 analyzed for EBA	12% (5 patients)	H 300 mg 5 d	Mean EBA (in log10 CFU/mL/d) = 0.77	NS
					R 600 mg 5 d	0.28
					M 400 mg 5 d	0.53
	Pletz et al [19] 2004	1 site in Germany	17 enrolled/17 analyzed	0% (excluded)	H 6 mg/kg 5 d	Mean EBA (in log10 CFU/mL/d) = 0.21	NS
					M 400 mg 5 d	0.27
	Johnson et al [20] 2006	≥3 sites in Brazil	40 enrolled/38 analyzed in extended EBA	0% (excluded)	H 300 mg 7 d	Mean EBA between d2–7 (in log10 CFU/mL) = 0.08	NS
					L 1000 mg 7 d	0.18
					M 400 mg 7 d	0.17
					G 400 mg 7 d	0.17
Reference of Clinical Trial and Study Period		Number and Location of Clinical Sites	Number of Subjects Enrolled/Analyzed	Proportion of HIV Infected Patients	Regimen	Negative Sputum at 8 wks (Solid Medium)	P (vs Control)
Phase 2b	Burman et al [24] July 2003–March 2005	22 sites in 4 countries in North America and Africa	336 enrolled/277 analyzed	22% (60 patients)	2RHZE	71%a	NS
					2RHZM	71%a
	Conde et al [25] October 2004–March 2007	1 site in Brazil	170 enrolled/146 analyzed in mITT	3% (5 patients)	2RHZE	63%	.03 (mITT)
					2RHZM	80%
	Rustomjee et al [26] June 2004–June 2005	4 sites in South Africa	217 enrolled/ 205 analyzed	59% (127 patients)	2RHZE	64%	NS
					2RHZM	82%
					2RHZG	77%
	Dorman et al [23] February 2006–March 2007	22 sites in 5 countries in the Americas, Africa and Europe	443 enrolled/381 analyzed in mITT	11% (35 patients)	2RHZE	87%	.19 (mITT)
					2RMZE	91%

Abbreviations: CFU, colony-forming unit; EBA, early bactericidal activity; HIV, human immunodeficiency virus; mITT, modified intention to treat; NS, not significant.

^a Combined results on solid and liquid media.