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

Completed · Phase 4

Conditions studied: HIV Infections, Lipodystrophy

In brief

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).

Key facts

Study ID

NCT00005764

Run by

Glaxo Wellcome

People needed

100

Starts

2000-05-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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