title: Efficacy testing of recombinant human immunodeficiency virus (HIV) gp160 as a therapeutic vaccine in early-stage HIV-1-infected volunteers. rgp160 Phase II Vaccine Investigators.
abstract: A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early-stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
authors.affiliation: Walter Reed Army Institute of Research, Division of Retrovirology, Rockville, MD 20850, USA. dbirx@hiv.hjf.org
authors.forename: D L
authors.initials: DL
authors.lastname: Birx
authors.forename: L D
authors.initials: LD
authors.lastname: Loomis-Price
authors.forename: N
authors.initials: N
authors.lastname: Aronson
authors.forename: J
authors.initials: J
authors.lastname: Brundage
authors.forename: C
authors.initials: C
authors.lastname: Davis
authors.forename: L
authors.initials: L
authors.lastname: Deyton
authors.forename: R
authors.initials: R
authors.lastname: Garner
authors.forename: F
authors.initials: F
authors.lastname: Gordin
authors.forename: D
authors.initials: D
authors.lastname: Henry
authors.forename: W
authors.initials: W
authors.lastname: Holloway
authors.forename: T
authors.initials: T
authors.lastname: Kerkering
authors.forename: R
authors.initials: R
authors.lastname: Luskin-Hawk
authors.forename: J
authors.initials: J
authors.lastname: McNeil
authors.forename: N
authors.initials: N
authors.lastname: Michael
authors.forename: P
authors.initials: P
authors.lastname: Foster Pierce
authors.forename: D
authors.initials: D
authors.lastname: Poretz
authors.forename: S
authors.initials: S
authors.lastname: Ratto-Kim
authors.forename: P
authors.initials: P
authors.lastname: Renzullo
authors.forename: N
authors.initials: N
authors.lastname: Ruiz
authors.forename: K
authors.initials: K
authors.lastname: Sitz
authors.forename: G
authors.initials: G
authors.lastname: Smith
authors.forename: C
authors.initials: C
authors.lastname: Tacket
authors.forename: M
authors.initials: M
authors.lastname: Thompson
authors.forename: E
authors.initials: E
authors.lastname: Tramont
authors.forename: B
authors.initials: B
authors.lastname: Yangco
authors.forename: R
authors.initials: R
authors.lastname: Yarrish
authors.forename: R R
authors.initials: RR
authors.lastname: Redfield
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology / Q000628:therapy* / Q000821:virology; D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D005260:Female; D019302:HIV Envelope Protein gp160 / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins / Q000276:immunology; D014614:Vaccines, Synthetic / Q000627:therapeutic use*
chemical_list: D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D011994:Recombinant Proteins; D014614:Vaccines, Synthetic