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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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