A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
2 other identifiers
interventional
100
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
May 30, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 2001
May 30, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (31)
THE Clinic
Los Angeles, California, 90008, United States
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048, United States
St Lukes Medical Group
San Diego, California, 92101, United States
UCSD Treatment Ctr
San Diego, California, 921036329, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Duval County Health Department
Jacksonville, Florida, 32206, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244, United States
Infectious Disease Specialists of NJ
Union, New Jersey, 07083, United States
Infectious Diseases Assoc of Brooklyn
Brooklyn, New York, 11215, United States
Long Island College Hospital
Brooklyn, New York, 11217, United States
Mt Vernon Hospital
Mount Vernon, New York, 10550, United States
Dr Lawrence Fontana
New York, New York, 10003, United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, 10003, United States
Howard Grossman
New York, New York, 10011, United States
Boriken Neighborhood Health Center
New York, New York, 10035, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468, United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030, United States
Summa Health System
Akron, Ohio, 44304, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Gathe, Joseph, M.D.
Houston, Texas, 77004, United States
Diversified Med Practices, PA
Houston, Texas, 77027, United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Swedish Med Ctr
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 30, 2000
First Posted
August 31, 2001
Study Start
May 1, 2000
Last Updated
June 24, 2005
Record last verified: 2001-06