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Home > "A" Clinical Trials Conditions > A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients  A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
For Condition: HIV Infections,Lipodystrophy
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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).
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Infectious Diseases Assoc of Brooklyn
Brooklyn, New York, 11215
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Dr Lawrence Fontana
New York City, New York, 10003
United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York City, New York, 10003
United States
Duval County Health Department
Jacksonville, Florida, 32206
United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
United States
St Lukes Medical Group
San Diego, California, 92101
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030
United States
Summa Health System
Akron, Ohio, 44304
United States
THE Clinic
Los Angeles, California, 90008
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
North Broward Hosp District / HIV Clinical Research
Ft. Lauderdale, Florida, 33311
United States
Howard Grossman
New York City, New York, 10011
United States
Long Island College Hospital
Brooklyn, New York, 11217
United States
Diversified Med Practices, PA
Houston, Texas, 77027
United States
Bronx Veterans Affairs Med Ctr
Bronx, New York, 10468
United States
Mt Vernon Hospital
Mt. Vernon, New York, 10550
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
Swedish Med Ctr
Seattle, Washington, 98122
United States
Boriken Neighborhood Health Center
New York City, New York, 10035
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
United States
Gathe, Joseph, M.D.
Houston, Texas, 77004
United States
Central Texas Clinical Research
Austin, Texas, 78705
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Jersey Shore Med Ctr
Neptune, New Jersey, 07753
United States
UCSD Treatment Ctr
San Diego, California, 921036329
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
Additional Information:
Study ID Numbers: 238T; ESS40010
Study Start Date: May 2000
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005764
Other Hiv Infections Studies:
1. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
2. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
3. Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
4. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
5. Metabolism and Body Shape of Healthy Children and Children with Chronic Infections
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Ft. Lauderdale Clinical Trials
A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
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