Calendario›GILD›Nelfinavir mesylate

Nelfinavir mesylate

A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient

Ensayo de GILEAD SCIENCES, INC. en Infeccion por VIH.

Más ensayos de: Infección por VIH.

Fase

Fase 2

Estado

Completado

Participantes

120

previstos

Centros

15

Qué significa cada fase y cada estado.

Estudio de intervención, doble ciego.

Cómo lo describe el promotor

En el documentoEn inglés, del registroTo evaluate the safety and tolerance of the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.

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Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00002184), actualizada en jun 2005.