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

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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)

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.

Study Phase

Phase 4

Study Type

Interventional

Condition

HIV Infections

Intervention

Lamivudine/Zidovudine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

May 2000

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00005764

Organization ID

238T

Secondary IDs

ESS40010

Study Sponsor

Glaxo Wellcome

Study Sponsor

, ,

Verification Date

June 2001