Clinical trial NCT00005764: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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