About the Authors
- Fawaz Mzayek
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Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Epidemiology, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Haiyan Deng
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Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Frances J Mather
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Affiliation Department of Biostatistics, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Elizabeth C Wasilevich
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Current address: Elizabeth C. Wasilevich, Bureau of Epidemiology, Michigan Department of Community Health, East Lansing, Michigan, United States of America
Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Epidemiology, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Huayin Liu
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Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Christiane M Hadi
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Affiliation Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- David H Chansolme
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Current address: David H. Chansolme, Oklahoma City, Oklahoma, United States of America
Affiliation Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Holly A Murphy
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Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Bekir H Melek
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Affiliation Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Alan N Tenaglia
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Current address: Alan N. Tenaglia, Scottsdale, Arizona, United States of America
Affiliation Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- David M Mushatt
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Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America
- Albert W Dreisbach
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Current address: Albert W. Dreisbach, Division of Nephrology, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States of America
Affiliations Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Pharmacology, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Tulane–Louisiana State University–Charity Hospital General Clinical Research Center, New Orleans, Louisiana, United States of America
- Juan J. L Lertora
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e¤ Current address: Juan J. L. Lertora, Clinical Pharmacology Program, NIH Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America
Affiliations Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Pharmacology, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Tulane–Louisiana State University–Charity Hospital General Clinical Research Center, New Orleans, Louisiana, United States of America
- Donald J Krogstad
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*To whom correspondence should be addressed. E-mail: krogstad@tulane.edu
Affiliations Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, United States of America, Tulane–Louisiana State University–Charity Hospital General Clinical Research Center, New Orleans, Louisiana, United States of America
Competing Interests
The authors have declared that no competing interests exist.
Author Contributions
Biostatistical issues, including randomization, study design, and power calculations were directed wholly or in part by FM and FJM. FM and ECW assisted with volunteer recruitment and coordination and data management. Determinations of drug concentrations in blood and urine were performed by HD using an HPLC assay she developed for this purpose. Identification of the structures of AQ-13 and CQ metabolites was performed by HL. Volunteer screening, enrollment, and examination during the inpatient studies and outpatient follow-ups were performed by a number of physicians, with major contributions from CH, DHC, and HAM. Review of ECGs and Holter recordings for screening and drug toxicity were performed by two cardiologists, BHM for the 600, 700 and 1,500/1,750 mg doses, and ANT for the 10, 100 and 300 mg doses. Holter recording analyses were performed by FM. Expertise in clinical trials based on the HIV experience and on human study participant issues was provided by DMM. Pharmacokinetic calculations using the WinNonlin software were performed by FM with the aid of AWD. Expertise in clinical pharmacokinetics was provided by JJLL. General oversight was provided by the principal investigator, DJK.