AEGiS-06CROI: ABT-378/ritonavir therapy in antiretroviral-naïve HIV-I infected patients for 24 weeks.

6th Conference on Retroviruses and Opportunistic Infections


Chicago, IL - January 31-February 4, 1999



ABT-378/ritonavir therapy in antiretroviral-naïve HIV-I infected patients for 24 weeks.

Conf Retroviruses Opportunistic Infect 1999 Jan 31-Feb 4; 6th:69 (abstract no. 15)

Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A; Northwestern University, Chicago, IL.

Objective: To assess the safety, tolerability and antiviral activity of the protease inhibitor ABT-378/ritonavir (ABT-378/r) 200/100 mg BID, 400/100 mg BID, and 400/200 mg BID with stavudine and lamivudine.

Methods: Two groups of antiretroviral-naïve patients were randomly as-signed to a blinded ABT-378/r dose: Group I (200/100 mg or 400/100 mg BID); Group II (400/100 mg or 400/200 mg BID) and treated for 24 weeks.

Results: Median baseline HIV RNA and CD4 cell count for Group I were 5.0 log10 copies/mL and 424 cells/mm3, and for Group II, 4.8 log10 copies/microliter and 313 cells/mm3, respectively. After 24 weeks, the median HIV RNA decrease from baseline was 2.4 log10 copies/mL, and 27/29 (93%) patients in Group I had HIV RNA <400 copies/mL (Roche Amplicor). At week 20, 43/45 (96%) patients in Group II had HIV RNA <400 copies/mL. Ultrasensitive PCR was performed for Group I at 16 weeks, and 73% of patients had <50 copies/mL. CD4+T-lymphocytes increased approximately 110 cells/microliter. The most common adverse events were diarrhea, asthenia, and headache. All doses have been well tolerated with no discontinuations for adverse events related to study medications.

Conclusions: All ABT-378/r doses were demonstrated to have excellent tolerability and antiretroviral activity with ≥ 93% of antiretroviral-naïve patients with HIV RNA <400 copies after 20-24 weeks of treatment.

Keywords: AEGIS, Ritonavir, HIV, Pyrimidinones, Stavudine, CD4 Lymphocyte Count, Lamivudine, Anti-HIV Agents, Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, HIV Infections, HIV Protease, ABT 378, Human, therapy, pathogenicity, drug therapy, AIDSKWDaegis,ritonavir,hiv,pyrimidinones,stavudine,cd4lymphocytecount,lamivudine,anti-hivagents,reversetranscriptaseinhibitors,hivproteaseinhibitors,hivinfections,hivprotease,abt378,human,therapy,pathogenicity,drugtherapy,aids

1999-01-31
15

Copyright © 1999 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed from National Library of Medicine.