RAltegravir Switch STudy: effects on Endothelial Recovery

• Conditions: -Human Imunodeficiency Virus (HIV) infection-Endothelial dysfunction in HIV-infected patients-immune activation in HIV-infected patients-cardiovascular complications in HIV-infecetd patients; MedDRA version: 14.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.0Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10048554Term: Endothelial dysfunctionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003298-26-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

-Age = 18 years
-HIV-1 infection
-Treatment with antiretroviral regimen containing lopinavir-ritonavir for at least the previous 3 months
-No other protease inhibitors besides lopinavir-ritonavir in antiretroviral regimen
-Subjects must have a minimum period of viral suppression (plasma HIV-RNA < 50 copies/ml) of 6 months
-Subjects will not have a history of virological failure on antiretroviral therapy
-Results of previous resistance testing allowing replacement of lopinavir-ritonavir by raltegravir
-CD4+ cell count > 200 cells/µL
-Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

-Pregnancy
-Breastfeeding
-Raltegravir hypersensitivity
-Treatment of underlying malignancy
-Renal insufficiency requiring dialysis
-Acute or decompensated chronic hepatitis (Child-Pugh score C)
-Modification of antiretroviral regimen in the previous 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified