Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue
NCT ID: NCT00647946
Last Updated: 2008-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2003-02-28
2006-02-28
Brief Summary
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This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed tomography (CT) scans and improved cholesterol and triglycerides.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Stop zidovudine (ZDV) or stavudine (d4T) and start tenofovir DF 300mg once daily along with the other antiviral drugs that are used as part of their HAART regimen
tenofovir DF
tenofovir DF 300mg once daily along with the other antiviral drugs
B
Stop zidovudine (ZDV) or stavudine (d4T) and start abacavir 300mg twice daily along with the other antiviral drugs that are used as part of their HAART regimen
abacavir 300mg twice daily
abacavir 300mg twice daily along with the other antiviral drugs
Interventions
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tenofovir DF
tenofovir DF 300mg once daily along with the other antiviral drugs
abacavir 300mg twice daily
abacavir 300mg twice daily along with the other antiviral drugs
Eligibility Criteria
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Inclusion Criteria
* Subjects who are HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
* Female subjects of childbearing potential must have a negative serum pregnancy test (beta-HCG) within 28 days of trial day 1. Women of childbearing potential must agree to use a barrier method of contraception
* Female subjects must not be pregnant or lactating
* Subjects who in the opinion of the investigator have the ability to understand and provided written informed consent to participate in the trial
* Subjects who in the opinion of the investigator have clinical lipoatrophy at \> 1 body/facial site
* Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV)
* Subjects who are stable on current therapy for \>16 weeks
* Subjects with no prior exposure to tenofovir, abacavir, or adefovir
* Subjects with no known K65R, 69S mutations or 3 or more thymidine analogue mutations
* Subjects with documented viral load \<50 copies/ml on 2 consecutive occasions including most recent clinic attendance
Exclusion Criteria
* Currently active opportunistic disease or documented wasting syndrome
* Currently receiving chemotherapy for malignancy
* Subjects who in the opinion of the investigator are unlikely to retain viral response after switching based on treatment or transmission history
* Currently receiving an insulin sensitising agent (glitazone or metformin)
* Anabolic steroids in the last 16 weeks other than testosterone at replacement doses (\<250mg/2 weekly)
* Growth hormone use in the last 16 weeks
* Statin therapy (HMG CoA reductase inhibitor) commenced in the last 16 weeks (patients stable on statins my be included)
* Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations
* Receiving concurrent medications that - in the opinion of the investigator and according to drug product labelling - will result in clinically significant interactions with tenofovir or abacavir
* Pregnant or breast feeding
* Previously received more than 3 months zidovudine monotherapy
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences
Principal Investigators
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Geoff Cotton
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Gilead Sciences
Abingdon, Cambridge, United Kingdom
Countries
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Related Links
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Study results
Other Identifiers
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GS-UK-104-1008
Identifier Type: -
Identifier Source: org_study_id