A randomized, comparative study of lamivudine plus stavudine, with indinavir or nelfinavir, in treatment-experienced HIV-infected patients.
OBJECTIVE
To compare adherence and clinical outcome with two modalities of highly active antiretroviral therapy (HAART), in HIV-infected patients.


METHODS
Randomized, open-label, prospective study.


METHODS
Tertiary care centre in Spain.


METHODS
A total of 112 non-naive HIV-infected patients, recruited from March 1998 through August 1998, were studied.


METHODS
Triple drug therapy with stavudine and lamivudine, plus indinavir or nelfinavir.


METHODS
Adherence, side-effects, and immunological, virological, and clinical efficacy of treatment were assessed at 3-month intervals.


RESULTS
After a median follow-up of 9 months, 32% of patients in the indinavir group versus 50% of those in the nelfinavir group showed adequate adherence in all clinical appointments (P= 0.0559). Adherence was superior in the nelfinavir group in every visit. After 6 months of treatment 48% of subjects in the indinavir group and 70% of those in the nelfinavir group exhibited adequate adherence (P= 0.0311). After 9 months 35% of patients in the indinavir group and 59% of those in the nelfinavir group showed adequate adherence (P= 0.0291). Side-effects provoked discontinuation of treatment in 34% of patients in the indinavir group and 12% of patients in the nelfinavir group (P= 0.0073). Immunological and virological efficacy were similar in both groups.


CONCLUSIONS
Adherence to a HAART regimen with stavudine plus lamivudine plus nelfinavir was superior to a regimen with stavudine plus lamivudine plus indinavir. Side-effects provoked more discontinuation of treatment in the indinavir group than in the nelfinavir group.
Roca
B
B
Division of Infectious Diseases, Hospital General, Public Health Department, Castellón, Spain.
Gómez
C J
CJ
Arnedo
A
A
D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D019469:Indinavir / Q000009:adverse effects / Q000627:therapeutic use; D007674:Kidney Diseases / Q000139:chemically induced; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D019888:Nelfinavir / Q000009:adverse effects / Q000627:therapeutic use; D010349:Patient Compliance; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D018119:Stavudine / Q000627:therapeutic use*; D016896:Treatment Outcome
D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D019469:Indinavir; D018119:Stavudine; D019888:Nelfinavir