Objective:The relationship between HIV-1 viral load and the risk for opportunistic infection (OI) was examined in Adult AIDS Clinical Trial Group (AACTG) 722, a virology substudy of AACTG 323: a phase 4 randomized study designed to examine the use of chronic suppressive versus episodic fluconazole therapy.
Methods:The primary analysis used a case-control sampling scheme with two controls per “case” (subjects that developed an OI) matched by gender, age, and time on study. Forty-five cases and matched controls were identified and used in the analysis.
Results:Study 722 accrued 518 subjects between 5/97 and 11/99. Forty-five subjects developed serious OIs or refractory candidiasis. Median baseline CD4 count was 24 cell/mm3 for cases and 46 for controls (p = .003). Median viral load (VL) was 5.02 log10 copies/mL for cases and 4.08 for controls (p = .002). Multivariate analysis found four independent variables associated with time to OI: baseline VL and CD4 (RR = 2.2 per log increment and 6.0 per 50-cell increment, respectively), a one log increase in VL at any time (RR = 15), and history of an OI (RR = 5.2).
Conclusions:VL and changes in VL were independently associated with risk of development of OIs in a prospective study and should be considered by clinicians when assessing patients for risk of OI.
Address correspondence and reprint requests to: Susan Swindells, University of Nebraska Medical Center, 985400 Nebraska Medical Center Omaha, NE 68198-5400 U.S.A. e-mail: firstname.lastname@example.org
Supported by grants from the AIDS Clinical Trial Group, National Institute of Allergy and Infectious Diseases (5 U01 A138855 and AI 27661).
Presented, in part, at the 9th Conference on Retroviruses and Opportunistic Infection, February 2002, Seattle, Washington, U.S.A.
Manuscript received January 28, 2002; accepted March 26, 2002.
© 2002 Lippincott Williams & Wilkins, Inc.