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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00006190 |
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Date of registration:
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25/08/2000 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
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Scientific title:
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The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients |
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Date of first enrolment:
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November 2000 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00006190 |
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Study type:
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Interventional |
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Study design:
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Masking: Double-Blind, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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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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Dr. Abhimanyu Garg |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Name:
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Dr. Dolores Peterson |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Name:
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Dr. Ruth Berggren |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- CD4 count > 200 cells/mm
- HIV RNA (viral load) <= 100,000 copies/ml
- No previous antiviral therapy
Exclusion Criteria:
- AIDS or opportunistic infections
- Active intravenous drug users
- Use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications,
oxandrolone, megace, dehydroepiandrosterone.
- Subjects with diabetes mellitus
- Subjects who consume > 2 alcoholic drinks per day
- Pregnant women, premenopausal women unless adequate birth control is in use.
- Acute or chronic liver diseases, liver enzymes elevations > 2.5 times the upper limit
of normal.
- Anemia, an Hct < 35% for men, or < 32% for women.
- Abnormal thyroid function tests.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Lipodystrophy
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Intervention(s)
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Drug: Nelfinavir mesylate
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Drug: Lamivudine
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Drug: Efavirenz
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Drug: Stavudine
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Secondary ID(s)
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lipod (completed)
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RO1DK56583-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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