title: Prognostic value of plasma human immunodeficiency virus type 1 (HIV-1) RNA levels in patients with advanced HIV-1 disease and with little or no prior zidovudine therapy. AIDS Clinical Trials Group Protocol 116A/116B/117 Team.
abstract: The association of plasma human immunodeficiency virus type 1 (HIV-1) RNA level at study entry and over time with clinical progression was evaluated in 187 patients from AIDS Clinical Trials Group protocol 116A who had little or no prior zidovudine treatment. Three-fold-higher HIV-1 RNA levels at study entry and 3-fold increases by week 8 were associated with progression (relative hazard [RH], 1.67; 95% confidence limits [CL], 1.20, 2.32; and RH, 1.45; CL, 1.02, 2.05, respectively). Having 3-fold-higher CD4 cell count at entry was independently associated with a 52% reduction in risk for progression (adjusted RH, 0.48; CL, 0.33, 0.70). When stratified by length of prior zidovudine therapy, RNA level was predictive in drug-naive patients (adjusted RH, 1.87; CL, 1.23, 2.85) but not predictive in patients with up to 16 weeks of prior therapy (adjusted RH, 1.11; CL, 0.70, 1.76). Analysis suggests that the acquisition of mutations at HIV-1 reverse transcriptase codons 215 and 74 is associated with subsequent increases in HIV-1 RNA level (relative risk, 7.00; CL, 0.86, 56.90).
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Welles
authors.forename: J B
authors.initials: JB
authors.lastname: Jackson
authors.forename: B
authors.initials: B
authors.lastname: Yen-Lieberman
authors.forename: L
authors.initials: L
authors.lastname: Demeter
authors.forename: A J
authors.initials: AJ
authors.lastname: Japour
authors.forename: L M
authors.initials: LM
authors.lastname: Smeaton
authors.forename: V A
authors.initials: VA
authors.lastname: Johnson
authors.forename: D R
authors.initials: DR
authors.lastname: Kuritzkes
authors.forename: R T
authors.initials: RT
authors.lastname: D'Aquila
authors.forename: P A
authors.initials: PA
authors.lastname: Reichelderfer
authors.forename: D D
authors.initials: DD
authors.lastname: Richman
authors.forename: R
authors.initials: R
authors.lastname: Reichman
authors.forename: M
authors.initials: M
authors.lastname: Fischl
authors.forename: R
authors.initials: R
authors.lastname: Dolin
authors.forename: R W
authors.initials: RW
authors.lastname: Coombs
authors.forename: J O
authors.initials: JO
authors.lastname: Kahn
authors.forename: C
authors.initials: C
authors.lastname: McLaren
authors.forename: J
authors.initials: J
authors.lastname: Todd
authors.forename: S
authors.initials: S
authors.lastname: Kwok
authors.forename: C S
authors.initials: CS
authors.lastname: Crumpacker
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000276:immunology / Q000821:virology*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D008297:Male; D011379:Prognosis; D012367:RNA, Viral / Q000097:blood*; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine