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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005764
• Other study ID #: 238T
• Secondary ID: ESS40010
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2000
• Last updated: June 23, 2005
• Start date: May 2000

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lipodystrophy

Intervention

Drug:
• Lamivudine/Zidovudine

• Abacavir sulfate

• Lamivudine

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	Central Texas Clinical Research	Austin	Texas
United States	Bronx Veterans Affairs Med Ctr	Bronx	New York
United States	Infectious Diseases Assoc of Brooklyn	Brooklyn	New York
United States	Long Island College Hospital	Brooklyn	New York
United States	Univ of North Carolina / SOCA	Chapel Hill	North Carolina
United States	Northstar Med Clinic	Chicago	Illinois
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Diversified Med Practices, PA	Houston	Texas
United States	Gathe, Joseph, M.D.	Houston	Texas
United States	Univ of Texas / Med School at Houston	Houston	Texas
United States	Duval County Health Department	Jacksonville	Florida
United States	THE Clinic	Los Angeles	California
United States	Tower Infectious Disease Med Ctr	Los Angeles	California
United States	Mt Vernon Hospital	Mt. Vernon	New York
United States	Jersey Shore Med Ctr	Neptune	New Jersey
United States	Boriken Neighborhood Health Center	New York	New York
United States	Dr Lawrence Fontana	New York	New York
United States	Howard Grossman	New York	New York
United States	Liberty Medical / Cabrini Hospital / Dept of Infec Diseases	New York	New York
United States	Philadelphia Veterans Administration Med Ctr	Philadelphia	Pennsylvania
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	St Lukes Medical Group	San Diego	California
United States	UCSD Treatment Ctr	San Diego	California
United States	Swedish Med Ctr	Seattle	Washington
United States	South Jersey Infectious Diseases Inc	Somers Point	New Jersey
United States	Infectious Disease Research Institute Inc	Tampa	Florida
United States	Infectious Disease Specialists of NJ	Union	New Jersey
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,