title: Higher rate of toxicity with no increased efficacy when hydroxyurea is added to a regimen of stavudine plus didanosine and nevirapine in primary HIV infection.
abstract: Twenty-four subjects presenting at a single treatment center with primary HIV infection were enrolled in a pilot study aimed to establish the possible role of hydroxyurea in this setting. Study participants were randomly assigned to receive or not to receive hydroxyurea in addition to stavudine (d4T) plus didanosine (ddI) and nevirapine (NVP). Seventy-five percent of patients without hydroxyurea had plasma HIV RNA below 50 copies/mL at 48 weeks by both intention-to-treat (ITT) and on-treatment (OT) analysis in comparison with 50% (ITT) and 67% (OT) of patients with hydroxyurea (p >.1). A median increase of >200 cells/mm3 was observed from baseline to week 48 whether or not hydroxyurea was included in the regimen. Overall, in 12 patients treated with hydroxyurea, 33 adverse events were reported versus 19 reported for 12 patients who did not receive hydroxyurea (p <.05). Our results suggest that that adding hydroxyurea to a regimen of d4T plus ddI and NVP increases toxicity without improving the antiviral effect.
authors.affiliation: Fundación Huesped and Department of Microbiology, School of Medicine, University of Buenos Aires, Argentina.
authors.forename: Carlos
authors.initials: C
authors.lastname: Zala
authors.forename: Horacio
authors.initials: H
authors.lastname: Salomon
authors.forename: Claudia
authors.initials: C
authors.lastname: Ochoa
authors.forename: Gustavo
authors.initials: G
authors.lastname: Kijak
authors.forename: Andrea
authors.initials: A
authors.lastname: Federico
authors.forename: Héctor
authors.initials: H
authors.lastname: Perez
authors.forename: Julio S G
authors.initials: JS
authors.lastname: Montaner
authors.forename: Pedro
authors.initials: P
authors.lastname: Cahn
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D006918:Hydroxyurea / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use; D014766:Viremia / Q000188:drug therapy
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D018119:Stavudine; D016049:Didanosine; D006918:Hydroxyurea