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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Lipodystrophy

Intervention: Lamivudine/Zidovudine (Drug); Abacavir sulfate (Drug); Lamivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Glaxo Wellcome

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).

Clinical Details

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 design: Primary Purpose: Treatment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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, 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, 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

Bronx Veterans Affairs Med Ctr, Bronx, New York 10468, 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, Mt. Vernon, New York 10550, United States

Boriken Neighborhood Health Center, New York, New York 10035, United States

Dr Lawrence Fontana, New York, New York 10003, United States

Howard Grossman, New York, New York 10011, United States

Liberty Medical / Cabrini Hospital / Dept of Infec Diseases, New York, New York 10003, 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

Diversified Med Practices, PA, Houston, Texas 77027, United States

Gathe, Joseph, M.D., Houston, Texas 77004, 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

Additional Information

Starting date: May 2000
Last updated: June 23, 2005

Page last updated: August 23, 2015

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