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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005764
First received: May 30, 2000
Last updated: June 23, 2005
Last verified: June 2001
  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 4

Study Type: Interventional
Study Design: Primary Purpose: 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)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00005764     History of Changes
Other Study ID Numbers: 238T, ESS40010
Study First Received: May 30, 2000
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on October 01, 2014