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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00050908 |
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Date of registration:
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30/12/2002 |
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Primary sponsor: |
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Public title:
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Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
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Scientific title:
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Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00050908 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Francesca J. Torriani, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Diego |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participation in ACTG A5142 .
- Able and willing to give written informed consent and to report current smoking
status.
- Men who have been on stable testosterone replacement for at least 3 months prior to
entry and plan to continue to receive a stable dose during the substudy may enroll.
Men who have discontinued testosterone therapy must be off for at least 3 months to
be eligible.
- Women receiving oral contraceptives, hormone replacement, or progestational
derivatives must have been on stable regimens for at least 3 months prior to
enrollment and must plan to remain on the same dose for the duration of the study.
Women who have discontinued such therapy must be off for at least 3 months to be
eligible.
Exclusion Criteria:
- Coronary heart disease, peripheral vascular disease, or cerebrovascular disease.
- Diabetes mellitus, with the exception of a previous history of gestational or
steroid-induced diabetes mellitus within 12 weeks prior to substudy entry.
- Insulin-sensitizing agents such as metformin, pioglitazone, and rosiglitazone.
- Lipid-lowering drugs within 6 weeks prior to substudy entry.
- Systemic glucocorticoids, long-acting inhaled steroids, and certain anabolic steroids
within 30 days prior to substudy entry.
- Uncontrolled hypertension.
- Heavy use of vitamin supplements.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Secondary ID(s)
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ACTG A5152s
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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