AEGiS-13IAC: Sustained efficacy of nevirapine (NVP) in combination with two nucleosides in advanced HIV infected patients with prior zidovudine (ZVD) experience: A BI 1090 substudy.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Sustained efficacy of nevirapine (NVP) in combination with two nucleosides in advanced HIV infected patients with prior zidovudine (ZVD) experience: A BI 1090 substudy.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB607)

Pollard R, Green S, Holloway W; R. Pollard, University of Texas Medical Branch, Galveston, Texas, United States, Tel.: +1 409 772 4979, Fax: +1 409 772 3461, E-mail: rcurry@rdg.boehringer-ingelheim.com

BACKGROUND: Study BI 1090 was a 2256 patient international clinical endpoint comparison study of NVP versus placebo on a background of antiretroviral medications. HIV RNA copy number and CD4 counts were assessed to evaluate the effect of NVP.

METHODS: Plasmas from the first 239 patients with experience limited to ZDV and using ZDV/3TC were analysed. There were 117 patients assigned to NVP and 122 patients assigned to placebo. Analyses included response to below limit of detection (BLD, limit of detection 50 c/mL) at 6 months and 12 months for HIV RNA and CD4+ count. Patients were considered evaluable if they were observed during week 16 to 32 (6 month) or week 40 to 56 (12 month) time windows. Intent-to-treat (ITT) analysis that classifies non-evaluable patients as treatment failures is shown in brackets ' '.

RESULTS: Baseline HIV RNA was 77,754 c/mL (geometric mean); baseline CD4+ count was 120 cells/mm³ (mean). At 6 months and 12 months, 64% (57/89) '49%' and 61% (3/54) '28%' NVP patients were BLD, compared to 2% (2/91) '2%' and 4% (2/52) '2%' of placebo patients. At 6 and 12 months, evaluable NVP patients had mean CD4+ count changes of 94 cells/mm³ (N = 95) and 120 cells/mm³ (N = 76), compared to 27 cells/mm³ (N = 97) and 40 cells/mm³ (N = 65) for evaluable placebo patients. NVP was statistically significantly superior to placebo for all comparisons (p>0.01).

CONCLUSION: Sustained suppression of plasma HIV RNA with associated improvement in CD4+ count was achieved with NVP/ZDV/3TC in advanced ZDV-experienced patients

Keywords: AEGIS, Nevirapine, Zidovudine, HIV, HIV Infections, Lamivudine, CD4 Lymphocyte Count, Anti-HIV Agents, HIV Protease Inhibitors, HIV Seropositivity, Placebos, Human
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