Author Contributions: Dr Siliciano had full
access to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analyses.
Study concept and design: Nettles, Kieffer,
Quinn, Flexner, Carson, Ray, Siliciano.
Acquisition of data: Nettles, Kieffer, Kwon,
Monie, Han, Parsons, Cofrancesco, Quinn, Jackson, Flexner, Persaud, Siliciano.
Analysis and interpretation of data: Nettles,
Kieffer, Parsons, Gallant, Quinn, Jackson, Flexner, Carson, Ray, Persaud,
Drafting of the manuscript: Nettles, Kwon,
Parsons, Flexner, Carson, Ray, Siliciano.
Critical revision of the manuscript for important
intellectual content: Kieffer, Monie, Han, Cofrancesco, Gallant, Quinn,
Jackson, Flexner, Carson, Ray, Persaud, Siliciano.
Statistical analysis: Nettles, Quinn, Carson,
Obtained funding: Nettles, Carson, Siliciano.
Administrative, technical, or material support:
Kwon, Monie, Han, Parsons, Cofrancesco, Jackson, Flexner, Ray.
Study supervision: Kieffer, Flexner, Persaud,
Drs Nettles and Kieffer contributed equally to this article.
Financial Disclosures: Dr Nettles received
honoraria from Abbott. Dr Cofrancesco received a research grant from Agouron
Consultancies to study body composition in patients with HIV infection and
private research grants or funding from the Doris Duke Charitable Foundation;
was a consultant/advisor to Abbott, Gilead Sciences, GlaxoSmithKline, Ortho
Biotech, and Pfizer; received lecture sponsorship and honoraria for CME from
Agouron, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, and Ortho Biotech;
received HIV viral load assays for study in Thailand from Roche; and received
research funding from the AACTG, CDC, and NIH. Dr Gallant received grant/research
support or honoraria from or was a consultant to Abbott Laboratories, Boehringer-Ingelheim,
Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Roche Pharmaceuticals,
Tanox, Tibotec-Virco, Vertex, and ViroLogic. Dr Quinn is a government employee.
Dr Jackson received honoraria for lectures partially sponsored by Boehringer-Ingelheim
and Roche Diagnostics and received reagents and sponsored research funding
from Roche Molecular Systems for new assay evaluations. Dr Flexner was a consultant
to Merck and received research grants or honoraria from Abbott, Agouron/Pfizer,
Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, and Merck. Dr Carson
received government grant support including General Clinical Research Center
(NCRR), New Approaches to Brain Tumor Therapy (NCI), Atherosclerosis Risk
in Communities (NHLBI), and Study of Women with Congenital Adrenal Hyperplasia
(NIH). Dr Ray received honoraria for CME programs from Agouron Pharmaceuticals,
Bristol-Myers Squibb, GlaxoSmithKline, and Roche Laboratories. Dr Persaud
received research grants or funding from the Doris Duke Charitable Foundation
and the Elizabeth Glaser Pediatric AIDS Foundation, and grants or research
funding from NIH/NIAID-RO1. Dr Siliciano was a consultant for Schering-Plough
on an unrelated project and received research reagents from Merck for an unrelated
Funding/Support: Clinical studies were carried
out through the Johns Hopkins University School of Medicine General Clinical
Research Center, which was supported by NIH grant M01-RR00052 from the National
Center for Research Resources. Dr Nettles was supported by NIAID grants F32
AI056696 and K08 AI060367 and by a grant from Bristol-Myers Squibb. The experimental
work was supported by NIH grants AI43222 and AI51178 and a grant from the
Doris Duke Charitable Foundation and the Howard Hughes Medical Institute.
Role of the Sponsors: The funding agencies
had no role in any aspect of the design, execution, or publication of this
Previous Presentation: Preliminary data representing
some of the work described herein were presented as an abstract (651) at the
11th Conference on Retroviruses and Opportunistic Infections; February 8-11,
2004; San Francisco, Calif; and as an abstract (H1134) at the 44th Interscience
Conference on Antimicrobial Agents and Chemotherapy; October 30-November 2,
2004; Washington, DC.
Acknowledgment: We acknowledge James Johnson
for assistance with drug concentration measurements.