Status:
COMPLETED
Effect of Atazanavir on Endothelial Function in HIV-Infected Patients
Lead Sponsor:
Foundation for Cardiovascular Research, Zurich
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infections
Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 ather...
Detailed Description
Indication: Dyslipidemia Type II in HIV-Infected Patients Primary Objectives: Change of flow-mediated dilation in the forearm after 6 months using the protease inhibitor atazanavir in a potent antivi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Known coronary artery disease, hypertension, peripheral artery disease, or cerebrovascular disease.
- Diabetes mellitus.
- 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.
- Participation in any other drug/treatment study.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00447070
Start Date
August 1 2004
End Date
May 1 2006
Last Update
May 27 2009
Active Locations (1)
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1
University Hospital Zurich, Infectiology
Zurich, Canton of Zurich, Switzerland, 8091