Association of Plasma Human Immunodeficiency Virus Type 1 RNA Level withRisk of Clinical Progression in Patients with Advanced Infection

Abstract

Human immunodeficiency virus (HIV)-1 RNA level in plasma was evaluated as a surrogate marker for disease progression in a clinical trial of advanced HIV-1 infection. Baseline HIV-1 RNA level was an independent predictor of disease progression (relative hazard [RH] for each doubling of HIV-1 RNA level, 1.26; 95% confidence interval [CI], 1.03-1.54; P = .02), after adjusting for the week 4 change in HIV-1 RNA level, baseline CD4 cell count, syncytium-inducing phenotype, clinical status at study entry, and therapy randomization. A 50% reduction in HIV-1 RNA level was associated with a 27% decrease in the adjusted risk of disease progression during the study (RH, 0.73; 95% CI, 0.52-1.02; P = .07). The partial validation of HIV-1 RNA as a predictor for clinical end points has implications for the use of HIV-1 RNA in clinical trials and practice.

Armored Long RNA Controls or Standards for Branched DNA Assay for Detection of Human Immunodeficiency Virus Type 1

“…Accurate determination of HIV type 1 (HIV-1) RNA levels is important for understanding the natural history of HIV infection, predicting the disease progression to AIDS, and determining the efficacy of antiretroviral therapies for a given patient (1,15,16).…”

Discordance between Viral Loads Determined by Roche COBAS AMPLICOR Human Immunodeficiency Virus Type 1 Monitor (Version 1.5) Standard and Ultrasensitive Assays Caused by Freezing Patient Plasma in Centrifuged Becton-Dickinson Vacutainer Brand Plasma Preparation Tubes

“…The ultrasensitive viral load determinations generally agreed with the results of the B-DNA (Bayer) viral load assays. If the plasma was transferred from the centrifuged plasma preparation tubes before freezing, standard and ultrasensitive results were concordant with each other and with values determined on plasma from lavender-topped EDTA tubes.Human immunodeficiency virus (HIV) viral load determinations represent the standard of care in the initial assessment of HIV-infected persons and in the subsequent management of the disease (4,11,13). Spurious high viral loads may cause patients to be started unnecessarily on antiretroviral therapy.…”

Therapy and Prophylaxis in Human Immunodeficiency Virus (Hiv) Infection

“…Thus, even moderate levels of HIV RNA appear to reflect very active HIV replication in tissue. Decline in plasma HIV RNA concentrations during therapy are strongly associated with a decrease in risk of subsequent disease progression [13]. Despite the strength of plasma viral load quantification as a prognostic and therapeutic marker certain caveats are important:- In view of the above independent predictors of clinical cure, although less powerful than viral load.…”