International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3215.
Francisco; on behalfAntunes, Hosp. Sta. Maria, Av. Prof. Egas Moniz, 1600 Lisboa, Portugal, Tel.: + 351 21 797 6242, Fax: + 351 21 793 8043, E-mail: ip231874@ip.pt
Background: Simplification of antiretroviral drug regimens, without loss of potency, is crucial to achieving adherence to therapy. This study compares the antiviral activity and safety of zalcitabine BID + zidovudine (ZDV) + a protease inhibitor (PI) to that of 3TC + ZDV + PI in antiretroviral-naive HIV-1 infected patients. Methods: 60 antiretroviral-naive patients (HIV RNA > 5000 copies/ml + CD4 cell count > 200/mm3 + no genotypic mutations to any study drug at baseline) will be randomised to receive zalcitabine (1.125 mg BID) + ZDV (300 mg BID) + PI (nelfinavir 1250 mg BID or saquinavir SGC 1600 mg BID) or 3TC (150 mg BID), ZDV + PI for 24 weeks. Results: A total of 26 patients have been randomised to therapy. Mean viral load at baseline was 4.89 and 5.00 log copies/ml in the two groups, respectively, with mean CD4 cell counts of 349 and 354 cells/mm3. Week 12 data are available for 11 patients, with a reduction in HIV RNA of -2.57 with zalcitabine and -2.48 log copies/ml with 3TC at this time. HIV RNA was > 400 copies/ml in 8/11 patients (72.7%) overall, and CD4 cell counts increased in both groups, with no significant differences between treatments reported. Both regimens were well tolerated, with gastrointestinal events the most frequently reported adverse effect in both groups. Conclusions: These preliminary data from this ongoing study suggest that zalcitabine is well tolerated and effective when administered twice daily in HAART regimens.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiretroviral Therapy, Highly Active
- Antiviral Agents
- CD4 Lymphocyte Count
- HIV
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- HIV-1
- Humans
- Lamivudine
- Protease Inhibitors
- Reverse Transcriptase Inhibitors
- Saquinavir
- Viral Load
- Zalcitabine
- Zidovudine
Other ID:
UI: 102239125
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