Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue
RAVE
A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)
1 other identifier
interventional
100
1 country
1
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 period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not correspond. Longer-term follow up of these patients is required. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2003
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedJune 30, 2008
June 1, 2008
1.7 years
March 27, 2008
June 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in total limb fat mass by DEXA scan
24 and 48 weeks
Secondary Outcomes (7)
Change in VAT by single slice L4 abdominal CT scan
24 and 48 weeks
Change in viral load measurements and CD4 cell count
24 and 48 Weeks
Change in fasting cholesterol and triglycerides
24 and 48 Weeks
Change in blood insulin and fasting glucose
24 and 48 Weeks
Change in blood lactate and anion gap
24 and 48 Weeks
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALStop 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
B
ACTIVE COMPARATORStop 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Gilead Sciences
Abingdon, Cambridge, CB1 6GT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Geoff Cotton
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
February 1, 2003
Primary Completion
October 1, 2004
Study Completion
February 1, 2006
Last Updated
June 30, 2008
Record last verified: 2008-06