A phase III, multicenter, randomized, open-label study to compare the antiretroviral activity and tolerability of efavirenz (EFV) + indinavir (IDV), versus EFV + zidovudine (ZDV) + lamivudine (3TC), versus IDV + ZDV + 3TC at 48 Weeks (Study DMP 266-006).
authors
K. Tashima, S. Staszewski, R. Stryker, P Johnson, M. Nelson, J. Morales-Ramirez, D.J. Manion, D. Farina, D. Labriola, N. Ruiz, and The Study 006 Investigator Team.
publication
6th Conference on Retroviruses and Opportunistic Infections. 31 Jan-4 Feb, 1999, Chicago, IL. Abstract LB16.
ABSTRACT
Background: Efavirenz (SUSTIVA(TM)) is a once-daily NNRTI. Study Design: Randomized, open-label study of PI-, NNRTI-, and 3TC-naïve patients, 86% male; 60% Caucasian; age, 36.3 (±8.2) years; 85% Tx-naïve; HIV-1 RNA; 4.77±0.57 log10 copies/mL; CD4 count; 345.3 ± 202.7 cells/mm3.
Methods of analysis: observed data (OBS), intent-to-treat:last observation carried forward (LOCF), and ITT:noncompleter=failure (NC=F).
Preliminary Efficacy Results at 48 weeks:
HIV-RNA ,<400 copies/mL
HIV-RNA <50 copies/mL
OBS
LOCF
NC=F
OBS
LOCF
NC=F
EFV+ZDV+3TC
*98%
*86%
*71%
*90%
*68%
*65%
EFV+IDV
83%
66%
53%
74%
55%
47%
IDV+ZDV+3TC
86%
61%
48%
79%
50%
44%
*Statistically significant EFV+ADV+3TC over IDV+ZDV+3TC (p<0.05).
Similar trends seen patients with baseline HIV-RNA >= 100,000 copies/ML. CD4 count increases ranged from 179-201cells/mm3. EFV-containing regimens were generally well tolerated with few new-onset AEs after week 12.
Conclusions: Compared to IDV+ZDV+3TC, EFV+ZDV+3TC offers superior efficacy with durability of response to at least 48 weeks, better tolerability and greater convenience. EFV+ZDV+3TC should be considered a superior first line therapy to the current PI-containing standard of care for HIV-infected patients including those with baseline HIV-RNA>=1000,000/mL.
