title: Diagnosis of HIV-Associated Oral Lesions in Relation to Early versus Delayed Antiretroviral Therapy: Results from the CIPRA HT001 Trial.
abstract: Oral mucosal lesions that are associated with HIV infection can play an important role in guiding the decision to initiate antiretroviral therapy (ART). The incidence of these lesions relative to the timing of ART initiation has not been well characterized. A randomized controlled clinical trial was conducted at the GHESKIO Center in Port-au-Prince, Haiti between 2004 and 2009. 816 HIV-infected ART-naïve participants with CD4 T cell counts between 200 and 350 cells/mm3 were randomized to either immediate ART initiation (early group; N = 408), or initiation when CD4 T cell count was less than or equal 200 cells/mm3 or with the development of an AIDS-defining condition (delayed group; N = 408). Every 3 months, all participants underwent an oral examination. The incidence of oral lesions was 4.10 in the early group and 17.85 in the delayed group (p-value <0.01). In comparison to the early group, there was a significantly higher incidence of candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex in the delayed group. The incidence of oral warts in delayed group was 0.97 before therapy and 4.27 post-ART initiation (p-value <0.01). In the delayed group the incidence of oral warts post-ART initiation was significantly higher than that seen in the early group (4.27 versus 1.09; p-value <0.01). The incidence of oral warts increased after ART was initiated, and relative to the early group there was a four-fold increase in oral warts if ART was initiated following an AIDS diagnosis. Based upon our findings, candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex indicate immune suppression and the need to start ART. In contrast, oral warts are a sign of immune reconstitution following ART initiation.
authors.affiliation: Weill Cornell Medical Center, New York, New York, United States of America.
authors.forename: Ashita S
authors.initials: AS
authors.lastname: Batavia
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti.
authors.forename: Rode
authors.initials: R
authors.lastname: Secours
authors.affiliation: University of California San Francisco School of Dentistry, San Francisco, California, United States of America.
authors.forename: Patrice
authors.initials: P
authors.lastname: Espinosa
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti.
authors.forename: Marc Antoine
authors.initials: MA
authors.lastname: Jean Juste
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti.
authors.forename: Patrice
authors.initials: P
authors.lastname: Severe
authors.affiliation: Weill Cornell Medical Center, New York, New York, United States of America.|Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti.
authors.forename: Jean William
authors.initials: JW
authors.lastname: Pape
authors.affiliation: Weill Cornell Medical Center, New York, New York, United States of America.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Fitzgerald
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis / Q000473:pathology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002180:Candidiasis, Oral / Q000175:diagnosis / Q000473:pathology; D018450:Disease Progression; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000473:pathology; D006560:Herpes Labialis / Q000175:diagnosis / Q000473:pathology; D006801:Humans; D008297:Male; D009061:Mouth Mucosa / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents