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tenofovir DF · RAVE

Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue

Ensayo de GILEAD SCIENCES, INC. en Lipodystrophy (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

100

previstos

Centros

1

Fin del objetivo primario

oct 2004

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2003.

Qué mide

Change in total limb fat mass by DEXA scan (24 and 48 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not correspond. Longer-term follow up of these patients is required. This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed tomography (CT) scans and improved cholesterol and triglycerides.

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Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00647946), actualizada en jun 2008.