Effect of Atazanavir on Endothelial Function in HIV-Infected Patients (ENDOPACT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
It is known that certain antiviral therapies, the socalled protease inhibitors, used in the treatment of HIV infection has an untowarded effect on the blood vessels, promoting early occurence of atherosclerosis. A a newer protease inhibitor, atazanavir, has been shown to have no negative effect on the levels of blood cholesterol and it is hypothesized that this may indicate that atazanavir is less prone to induce atherosclerosis. An early sign of atherosclerosis is a reduced vasomotion and this study investigate the influence of atazanavir on functionality of the conduit blood vessels compared to that of "standard" antiviral therapy.
Change of flow-mediated dilation in the forearm after 6 months using the protease inhibitor atazanavir in a potent antiviral therapy combination compared with a combination including current proteinase inhibitor.
Secondary Outcome Measures
Changes in plasma lipid profiles and further clinical chemistry parameters after 6 months of treatment compared to baseline.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women, 18 to 65 years old.
HIV-infection, documented by HIV-antibody ELISA and either positive immunoblot for HIV-antibodies or presence of HIV1 in blood.
Two consecutive Roche Ultrasensitive Amplicor tests showing plasma HIV-1 RNA < 50 copies/ml within 60 days prior to study entry.
CD4 count of > 100 cells/ml during 60 days prior to study entry.
Stable antiretroviral therapy for at least 12 weeks prior to study entry (a protease inhibitor plus 2 NRTIs).
Patient's treatment history allows, in the opinion of the investigator, atazanavir as replacement for current PI, i.e. continued viral suppression is expected based upon patient's treatment history and results of previous resistance testing, if available.
Fasting LDL-cholesterol > 3.0 mmol/l.
Known coronary artery disease, hypertension, peripheral artery disease, or cerebrovascular disease.
Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
Any contraindication for study medication.
Currently on non-nucleoside reverse transcriptase inhibitors (NNRTI) (previous exposure allowed).
Previous virologic failure on proteinase inhibitor-containing regimens which was not the consequence of poor adherence to therapy or drug adverse events; i.e. virologic failure was probably due to lack of potency of drug regimen, and may consecutively have resulted in protease resistance mutations.
Previously documented protease resistance mutations which are known to result in cross-resistance against atazanavir.
Any lipid lowering drugs within 4 weeks prior to study entry.
Testosterone or anabolic steroids unless stable therapy at least 12 weeks prior to study entry.
Systemic glucocorticoids, long-acting inhaled steroids or other immunomodulators within 30 days prior to study entry (prednisone < 10mg/day or equivalent is permitted.
Drug or alcohol abuse, in the opinion of the investigator rendering the patient unreliable for participation.