Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV-1 RNA Working Groups.
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.
Coombs
R W
RW
University of Washington, Seattle, 98144, USA.
Welles
S L
SL
Hooper
C
C
Reichelderfer
P S
PS
D'Aquila
R T
RT
Japour
A J
AJ
Johnson
V A
VA
Kuritzkes
D R
DR
Richman
D D
DD
Kwok
S
S
Todd
J
J
Jackson
J B
JB
DeGruttola
V
V
Crumpacker
C S
CS
Kahn
J
J
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000821:virology*; D000328:Adult; D018791:CD4 Lymphocyte Count; D005260:Female; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D008297:Male; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000097:blood*; D012306:Risk; D015215:Zidovudine / Q000627:therapeutic use
D012367:RNA, Viral; D015215:Zidovudine