Staszewski S; National Conference on Human Retroviruses and Related Infections.
Program Abstr Second Natl Conf Hum Retrovir Relat Infect Natl Conf Hum Retrovir Relat Infect 2nd 1995 Wash DC. 1995 Jan 29-Feb 2; 173.
European Lamivudine HIV Working Group, Goethe-Universitat, Frankfurt, Germany.
This three-arm, double-blind controlled trial compared the safety and efficacy of 24 weeks treatment with three regimens: (i) 3TC (300mg bid) + ZDV (200mg tid), (ii) 3TC (150mg bid) + ZDV (200mg tid) and (iii) ZDV monotherapy (200mg tid). Inclusion criteria were CD4 counts of 100-400 cells/mm3 and at least 6 months of prior ZDV treatment. 223 patients were randomized (75 to ZDV, 73 to ZDV/3TC 300mg, 75 to ZDV/3TC 150mg) and assessed for treatment efficacy using surrogate marker and viral load measurements out to 24 weeks. After 24 weeks, all patients were offered open-label treatment with 3TC and ZDV and followed out to week 48. All baseline characteristics recorded (excluding % females) were comparable between the three treatment arms. 54% were asymptomatic with a mean CD4 cell count of 251 and mean prior ZDV therapy of 24 months. With ZDV monotherapy the mean CD4 fell to 21 cells below baseline at 24 weeks. On 3TC/ZDV combination (300mg bid or 150mg bid) the mean CD4 rose to 47 cells at week 2 and this mean rise was sustained at 33 cells above baseline at week 24. Falls in ICD p24, beta-2-microglobulin and neopterin were greater and sustained for longer periods with the 3TC/ZDV combination therapy (either at the 300 or 150mg bid 3TC dose) than with ZDV monotherapy over the 24 week randomized treatment period. A full safety profile will also be presented.
Publication Types:
Keywords:
- Antigens, CD4
- CD4 Lymphocyte Count
- Female
- HIV-1
- Humans
- Lamivudine
- Zidovudine
- immunology
Other ID:
UI: 102213615
From Meeting Abstracts