A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients

June 23, 2005 updated by: Glaxo Wellcome

Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)

The purpose of this study is to see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are allocated as follows: a) zidovudine-naive patients switch Combivir for d4t and b) zidovudine-experienced or -intolerant patients switch abacavir for d4t. Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 2.2 mmol/L or more. Additionally, providers may choose to switch a maximum of 2 drugs, one of which must be d4t, in the regimen. Each patient receives 48 weeks of therapy. Visits are made at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Tests, including biopsies, are performed to measure changes in body fat distribution and changes in lactate levels. Virologic and immunologic outcomes, changes in physical signs of lipodystrophy, changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire, changes in lipid profile and other markers of metabolism, and safety parameters are evaluated also.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90008
        • The Clinic
      • Los Angeles, California, United States, 90048
        • Tower Infectious Disease Med Ctr
      • San Diego, California, United States, 92101
        • St Lukes Medical Group
      • San Diego, California, United States, 921036329
        • UCSD Treatment Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Jacksonville, Florida, United States, 32206
        • Duval County Health Department
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Med Ctr
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Diseases Inc
      • Union, New Jersey, United States, 07083
        • Infectious Disease Specialists of NJ
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Affairs Med Ctr
      • Brooklyn, New York, United States, 11215
        • Infectious Diseases Assoc of Brooklyn
      • Brooklyn, New York, United States, 11217
        • Long Island College Hospital
      • Mt. Vernon, New York, United States, 10550
        • Mt Vernon Hospital
      • New York, New York, United States, 10003
        • Dr Lawrence Fontana
      • New York, New York, United States, 10003
        • Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
      • New York, New York, United States, 10011
        • Howard Grossman
      • New York, New York, United States, 10035
        • Boriken Neighborhood Health Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997030
        • Univ of North Carolina / SOCA
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Veterans Administration Med Ctr
      • Pittsburgh, Pennsylvania, United States, 15221
        • Anderson Clinical Research
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Houston, Texas, United States, 77004
        • Gathe, Joseph, M.D.
      • Houston, Texas, United States, 77027
        • Diversified Med Practices, PA
      • Houston, Texas, United States, 77030
        • Univ of Texas / Med School at Houston
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Med Ctr

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

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are at least 18 years old.
  • Agree not to have intercourse 2 weeks before, during, and 2 weeks after study or agree to use effective methods of birth control.
  • Have had HIV-1 RNA levels less than 400 copies/ml on the 2 most recent measurements.
  • Have at least 1 of the following situations:
  • (a) at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in buttocks area; or
  • (b) an increase in lactate level greater than 2.2 mmol/L at the screening visit plus at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in the buttocks area; or
  • (c) an increase in lactate level greater than 2.2 mmol/L at screening visit plus at least 2 of the following: (1) shortness of breath, (2) weakness, (3) fast heartbeat, (4) recent weight loss (10 lbs. within the past 2 months), (5) pain and/or bloating in the abdomen, (6) nausea and/or vomiting and/or lack of appetite; or
  • (d) lactate level greater than 3.2 mmol/L at the screening visit.
  • Are able to read at a sixth-grade level.
  • Have taken d4T consistently for the 6 months before entering study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have diabetes or kidney failure.
  • Have any condition that makes them unable to participate in this study.
  • Are unable to take medications by mouth.
  • Have serious medical conditions, such as congestive heart failure or other heart disease, which would affect the safety of the patient.
  • Are taking or have taken abacavir plus Retrovir or Combivir.
  • Are pregnant or breast-feeding.
  • Are enrolled in other clinical studies.
  • Have had a reaction to or are unable to take abacavir and have taken Retrovir in the past.
  • Have taken hydroxyurea within the past 3 days or plan to take this drug during the study.
  • Have had chemotherapy or radiation therapy within 4 weeks prior to screening visit (except for local treatment for Kaposi's sarcoma) or plan to have such treatment during the study.
  • Have taken drugs that affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons, within 4 weeks prior to the screening visit.
  • Have had an HIV vaccine within 3 months of the screening visit.
  • Have taken recombinant Human Growth Hormone (r-hGH), megestrol acetate, medicines containing oxandrolone, oxymetholone, nandrolone, DHEA, or other testosterone derivatives, or glucocorticoids or other systemic steroids (except inhaled and topical steroids) in the last 4 months or plan to take these drugs during the study.

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?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

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

Sponsor

Glaxo Wellcome

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

May 1, 2000

Study Registration Dates

First Submitted

May 30, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238T
  • ESS40010

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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