Gathe J, Chu A, Kass C, Paxton W; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3236.
J. Gathe, Montrose Clinic, 215 Westheimer Street, Houston, TX 77006, United States, Tel.: +1 713 830 3000, Fax: +1 713 830 3084, E-mail: karen.leishman@agouron.com
Background: While clinical trials of antiretroviral agents assess the short-term ability and safety of drugs used to treat a chronic infection, the long-term efficacy of these agents to suppress HIV replication is less well known. The objective of this study was to determine the level of virologic control, immunologic reconstitution, and safety provided by 3 years of nelfinavir (NFV)+ zidovudine (AZT) + lamivudine (3TC) therapy. Methods: This was a multi-center observational study to determine the efficacy and safety of nelfinavir 750 mg TID in combination with standard doses of AZT + 3TC over 3 years time. Patients (N = 56) were ART naive with no prior exposure to NNRTIs or PIs, and had plasma HIV RNA > 15,000 copies/ml. The 56 patients followed for this time period were 84% male, predominantly Caucasian, and had a mean age of 38 years. Plasma HIV RNA levels, CD4 cell counts, and adverse events were assessed at clinic visits at least every three months. The patients' response to therapy was followed as the percentage of observed HIV RNA values below 50 copies/ml (Ultrasensitive assay). Results: At the start of the study the patients had a mean CD4 cell count of 310 cells/m L and a mean of 204,000 copies of HIV RNA/ml plasma. After 3 years patients on therapy (N = 39) had a mean change of RNA in their plasma of -3.21 logs, with 76.9% of patients having a plasma RNA level of > 50 copies/ml. After 3 years on therapy patients had a mean increase of 247(+/-170) cells/m L, to 556(+/-245) CD4 cells/m L. Treatment was well tolerated by the patients; diarrhea was the most commonly reported adverse event. Conclusion: Patients who remain on Nelfinavir combination therapy for 3 years demonstrate durable and potent antiretroviral activity as well as substantial replenishment of CD4 lymphocytes for the duration of this period. Nelfinavir combination therapy can effectively suppress HIV replication over long periods of time, is safe and is well tolerated.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Anti-Retroviral Agents
- CD4 Lymphocyte Count
- Combined Modality Therapy
- HIV
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Lamivudine
- Male
- Nelfinavir
- Reverse Transcriptase Inhibitors
- Zidovudine
Other ID:
UI: 102239146
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