search
Back to results

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

Primary Purpose

HIV Infections, Lipodystrophy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Abacavir sulfate
Lamivudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, Blood, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipodystrophy, Combivir, Lactic Acid, abacavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • THE Clinic
  • Tower Infectious Disease Med Ctr
  • St Lukes Medical Group
  • UCSD Treatment Ctr
  • Dupont Circle Physicians Group
  • North Broward Hosp District / HIV Clinical Research
  • Duval County Health Department
  • Infectious Disease Research Institute Inc
  • Northstar Med Clinic
  • Jersey Shore Med Ctr
  • South Jersey Infectious Diseases Inc
  • Infectious Disease Specialists of NJ
  • Bronx Veterans Affairs Med Ctr
  • Infectious Diseases Assoc of Brooklyn
  • Long Island College Hospital
  • Mt Vernon Hospital
  • Dr Lawrence Fontana
  • Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
  • Howard Grossman
  • Boriken Neighborhood Health Center
  • Univ of North Carolina / SOCA
  • Summa Health System
  • Case Western Reserve Univ
  • Philadelphia Veterans Administration Med Ctr
  • Anderson Clinical Research
  • Central Texas Clinical Research
  • Gathe, Joseph, M.D.
  • Diversified Med Practices, PA
  • Univ of Texas / Med School at Houston
  • Hampton Roads Med Specialists
  • Swedish Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 30, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00005764
Brief Title
A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
HIV-1, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, Blood, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipodystrophy, Combivir, Lactic Acid, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
THE Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90008
Country
United States
Facility Name
Tower Infectious Disease Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
St Lukes Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036329
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Duval County Health Department
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Jersey Shore Med Ctr
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Infectious Disease Specialists of NJ
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Facility Name
Bronx Veterans Affairs Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Infectious Diseases Assoc of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Long Island College Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11217
Country
United States
Facility Name
Mt Vernon Hospital
City
Mt. Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Dr Lawrence Fontana
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Boriken Neighborhood Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Univ of North Carolina / SOCA
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997030
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Philadelphia Veterans Administration Med Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Diversified Med Practices, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Univ of Texas / Med School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Swedish Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs