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

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Brief Title

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

Official Title

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)

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in total limb fat mass by DEXA scan

Secondary Outcome

 Change in VAT by single slice L4 abdominal CT scan

Condition

Lipodystrophy

Intervention

tenofovir DF

Study Arms / Comparison Groups

 A
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

February 2003

Completion Date

February 2006

Primary Completion Date

October 2004

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Geoff Cotton, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00647946

Organization ID

GS-UK-104-1008



Study Sponsor

Gilead Sciences


Study Sponsor

Geoff Cotton, Study Director, Gilead Sciences


Verification Date

June 2008