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Studien: AGMT_HIV1 |  VinInt 2nd Line | 

 


AGMT_HIV1

Coordinating Investigator: Prim. Univ.- Prof. Dr. Richard Greil
Fallzahl: 25
Start: Q2 2014 | Ende: Q3 2015
Status: geschlossen


One arm, Open label, Interventional, non-comparative Study to assess Changes in Lipids and Lipoproteins in HIV infected Women with Hyperlipidemia after Switch from boosted Protease Inhibitors to Raltegravir

Studiendesign

This is a 24-week, one arm, open-label, interventional, non-comparative muticentre study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Patients will be assessed at baseline, after 4, 12 and 24 weeks.

Changes of ongoing antiretroviral therapy other than the switch from protease inhibitor to raltegravir during the study are strongly discouraged unless required by the study physician. In analogy for patients on lipid lowering agents, a stable regimen for 3 months prior to study entry will be required. Modifications of the lipid lowering therapy during study are discouraged and will lead to exclusion (except reduction due to amelioration of the lipid profile).

Studienziele

The objective of the study is to assess the change of lipid profiles, observed in HIV infected women with hyperlipidemia after switch from boosted protease inhibitors to raltegravir.

Einschlusskriterien (Auszug)

• Documented HIV-1 infection in female patients, age ≥18 years
• Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) including indinavir, fosamprenavir, saquinavir, lopinavir, atazanavir, tipranavir, or darunavir for at least the previous 6 months
• Plasma HIV viral load <50 copies/ml (as recommended by the EACS Guidelines) on current boosted PI containing regimen for ≥ 6 months prior to study entry
• Patients receiving prophylaxis or treatment for an opportunistic infection or malignancy may be included as long as specific laboratory requirements were met approximately 1 month prior to screening
• Fasting LDL cholesterol >130 mg/dl
• Fasting triglycerides <450 mg/dl
• For patients on lipid lowering agents, a stable regimen for the past 3 months will be required



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VinInt 2nd Line

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Second Line Therapie mit Vinorelbine und Interferon-alpha-2c bei progredienten hämatogenen metastasierenden Hypernephrom (M1)



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