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A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
This study has been completed.
First Received: May 30, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00005764
  Purpose

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).


Condition Intervention Phase
HIV Infections
Lipodystrophy
Drug: Lamivudine/Zidovudine
Drug: Abacavir sulfate
Drug: Lamivudine
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Lactic acid Zidovudine Lamivudine Abacavir Abacavir sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 100
Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005764

  Show 31 Study Locations
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

Study ID Numbers: 238T, ESS40010
Study First Received: May 30, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005764     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Zalcitabine
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine
Lamivudine
Blood
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lipodystrophy
Combivir
Lactic Acid
abacavir

Study placed in the following topic categories:
Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Stavudine
Metabolic Diseases
Skin Diseases
Zalcitabine
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Didanosine
Anti-Retroviral Agents
HIV Seropositivity
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Abacavir
Retroviridae Infections
Metabolic Disorder
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lipodystrophy
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Metabolic Diseases
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Skin Diseases, Metabolic
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009