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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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16 December 2017 |
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Main ID: |
NCT00119379 |
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Date of registration:
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11/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
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Scientific title:
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Reversibility of Mitochondrial Toxicity in HIV Lipoatrophy |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00119379 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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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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Grace A. McComsey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Case Western Reserve University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of HIV lipoatrophy
- Receiving a stable stavudine- or zidovudine-containing ARV regimen
- HIV-1 RNA viral load less than 50 copies/ml
Exclusion Criteria:
- Coagulopathies or other bleeding disorders
- Diabetes requiring medication
- Creatinine clearance less than 50 ml/min
- Pregnancy or breastfeeding
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lipodystrophy
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Metabolic Diseases
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Nutrition Disorders
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HIV Infections
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Intervention(s)
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Drug: NucleomaxX
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Drug: Tenofovir Disoproxil Fumarate
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Primary Outcome(s)
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Change in Fat mtDNA Content
[Time Frame: Baseline to Week 48]
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Change in PBMC mtDNA
[Time Frame: Baseline to Week 48]
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Secondary Outcome(s)
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Change in Lumbar Spine Bone Mineral Density (BMD)
[Time Frame: Baseline to Week 48]
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Change in Limb Fat
[Time Frame: Baseline to Week 48]
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Change in Hip Bone Mineral Density (BMD)
[Time Frame: Baseline to Week 48]
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Change in Trunk Fat
[Time Frame: Baseline to Week 48]
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Secondary ID(s)
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R01AI060484
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1R01AI060484-01A2B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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