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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00647946
• Date of registration: 27/03/2008
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue RAVE
• Scientific 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)
• Date of first enrolment: February 2003
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00647946
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Geoff Cotton
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lipodystrophy

Intervention(s)

Drug: abacavir 300mg twice daily

Drug: tenofovir DF

Primary Outcome(s)

Change in total limb fat mass by DEXA scan [Time Frame: 24 and 48 weeks]

Secondary Outcome(s)

Change in fasting cholesterol and triglycerides [Time Frame: 24 and 48 Weeks]

Change in viral load measurements and CD4 cell count [Time Frame: 24 and 48 Weeks]

Change in VAT by single slice L4 abdominal CT scan [Time Frame: 24 and 48 weeks]

Change in blood insulin and fasting glucose [Time Frame: 24 and 48 Weeks]

Change in blood lactate and anion gap [Time Frame: 24 and 48 Weeks]

Change in bone mineral density by DEXA scan [Time Frame: 24 and 48 Weeks]

Incidence of adverse events [Time Frame: Upto 48 weeks]

Secondary ID(s)

GS-UK-104-1008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors