NCT00647946

Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 currently receiving zidovudine (ZDV) or stavudine (d4T) will be recruited.

Conditions

• Lipodystrophy

Interventions

Type	Name	Description
DRUG	tenofovir DF	tenofovir DF 300mg once daily along with the other antiviral drugs
DRUG	abacavir 300mg twice daily	abacavir 300mg twice daily along with the other antiviral drugs

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-10-01
• Completion: 2006-02-01
• First posted: 2008-04-01
• Last updated: 2008-06-30

Locations

1 site across 1 country: United Kingdom