Staszewski S, Keiser P, Gathe J, Haas D, Montaner J, Hammer S, Delfraissy JF, Cutrell A, Lafon S, Thorborn D, Pearce G, Spreen W, Tortell S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 70 (abstract no. 20).
University of Frankfurt, Germany.
Objective: Compare antiviral effect, CD4 response & safety of Ziagen (Abacavir, ABC [300mg BID]) + Combivir (3TC/ZDV) Vs Indinavir, (IDV, [800mg q8h]) + 3TC/ZDV out to 48 weeks. Methods: CNA3005, a randomized, double blind, international study, enrolled 562 ART-naive adults (vRNA>10,000c/mL; CD4>100c/mm3). Primary efficacy parameter is proportion of subjects with vRNA <400c/mL (Roche Amplicor Monitor). CD4 response was also assessed. Study is ongoing to 48 Wks; by Sep 15, 1998, 95% & 85% of subjects completed Wk 16 & Wk 24 respectively. Results: Preliminary data is blinded. Unblinded data will be presented. Median BL vRNA for Gp A was 4.92 log10 c/mL & 4.82 log10 c/mL for Gp B. Median BL CD4 counts were 352c/mm3 for Gp A & 363c/mm3 for Gp B. (Table: see text) Equivalent CD4 cell increases were observed in both groups; median ITT Increase at week 24 was 98 cells/mm3. Premature discontinuations were the same for both treatment groups (Wk 24; Gp A, n=66; Gp B, n=66). Conclusions: Antiviral efficacy & CD4 response with ABC/3TC/ZDV is equivalent to IDV/3TC/ZDV after 24 wks of therapy in this 48-week study in ART naive adults.
Publication Types:
Keywords:
- Adult
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- Combivir
- Dideoxynucleosides
- Drug Combinations
- Drug Therapy, Combination
- Humans
- Indinavir
- Lamivudine
- Zidovudine
- abacavir
- drug therapy
- therapy
Other ID:
UI: 102188637
From Meeting Abstracts