Immunomodulating Therapy and Improved Vaccination Responses by Cox-2 Inhibitor in HIV-infected Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic immune activation is a central feature of HIV-infection, and the degree of activated T-cells is a better predictor of disease progression and mortality than plasma viral load. The study hypothesis is that the anti-inflammatory substance etoricoxib will dampen chronic immune activation and improve the effect of T-cell dependent vaccines in HIV-1 infected patients.

The aim of the present study is to explore the efficacy of the study drug on markers of immune activation and vaccine responses, as well as safety of the study drug, in HIV-infected patients not receiving antiretroviral therapy and in patients on long-term effective ART who had CD4 counts < 500.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dag Kvale
• Collaborator: The Research Council of Norway
• Treatments: Cyclooxygenase 2 Inhibitors; Etoricoxib; Vaccines

Criteria

Inclusion Criteria:

ART- group: Confirmed diagnosis of HIV infection < 8 years prestudy

• no HIV-related clinical manifestations including acute HIV infection

• no current indication or use for antiretroviral treatment

• CD4+ count > 350 x 10^6 /l

• HIV RNA > 2000 copies/ml

ART+ group: Confirmed diagnosis of HIV infection

• no HIV-related clinical manifestations including acute HIV infection

• On stabile effective antiretroviral treatment (HIV RNA <50 copies/ml)

• CD4+ count < 500 x 10^6 /l

• HIV RNA > 2000 copies/ml

Exclusion Criteria:

• concomitant or sporadic use of NSAID, corticosteroids or other immune modulating therapies including interferon-alpha

• cholesterol > 7 M

• under treatment for hypertension or antihypertensive treatment indicated at inclusion

• cardiovascular events or stroke in parents, siblings or off-springs occurring < 55 years of age

• elevated serum creatinine

• diabetes type I or II

• known hypersensitivity for etoricoxib, capsule substances or sulphonamides

• active peptic ulcer or gastrointestinal haemorrhage

• history of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic reactions after taking acetyl salicylic acid or NSAID including COX-2 inhibitors

• pregnancy or insufficient birth control for females

• breastfeeding

• seriously deranged liver function

• creatine clearance < 30 ml/min

• inflammatory bowel disease

• heart failure (NYHA II-IV)

• established ischaemic heart disease, peripheral arteriosclerosis and/or cerebrovascular disease