Status:
COMPLETED
Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue
Lead Sponsor:
Gilead Sciences
Conditions:
Lipodystrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week per...
Detailed Description
This is a phase II, open-label, multicentre, randomised, two-arm study of 48 weeks duration. One hundred HIV infected individuals who have documented lipodystrophy at \> 1 body/facial site and current...
Eligibility Criteria
Inclusion
- Subjects who are male or female \> 18 years of age
- 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
- Subjects who in the investigator's opinion are unlikely to complete the 48 week trial period
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00647946
Start Date
February 1 2003
End Date
February 1 2006
Last Update
June 30 2008
Active Locations (1)
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1
Gilead Sciences
Abingdon, Cambridge, United Kingdom, CB1 6GT