Phase II Comparator Study of Substitution of Tenofovir or Abacavir Receiving Thymidine Analogue as Part of HAART.

April 7, 2008 updated by: Gilead Sciences

Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART.

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 tryglicerides.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat (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 tryglicerides.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who are male or female less than or equal to 18 years of age. 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. Able to understand and provide written informed consent in the opinion of the investigator. Subjects have clinical lipoatrophy at greater then or equal to 1 body/facial site in the investigator's opinion. Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV). Subjects who are stable on current therapy for greater than or equal to 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 less than 50 copies/mL on 2 consecutive occasions including most recent clinic attendance.

Exclusion Criteria:

  • Subjects who are unlikely to complete the 48 week trial period. Currently active opportunistic disease or documented wasting syndrome. Currently receiving chemotherapy for malignancy. Subjects who are unlikely to retain viral response after switching based on treatment or transmission history. Currently receiving an insulin sensitising agent (glitazone or metformin). Anabolic steriods in the last 16 weeks other than testosterone at replacement doses (less than or equal to 250 mg/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 may be included). Current alcohol or illicit drug use which may interfer 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 labeling will result in clinically significant interactions with tenofovir or abacavir. Pregnant or breast feeding. Previously received more than 3 months zidovudine monotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Claudio Avila, MD, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

December 23, 2005

First Submitted That Met QC Criteria

December 23, 2005

First Posted (Estimate)

December 28, 2005

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-02-1008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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