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HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) (HAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023620
Recruitment Status : Unknown
Verified December 2009 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:

This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy.

Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor.

The investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus.

This study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Pioglitazone Other: Observation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
Study Start Date : October 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Pioglitazone
10 male patients with lipodystrophy taking daily Pioglitazone 45 mg
Drug: Pioglitazone
Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

No Intervention: Observation/Comparison
10 male patients with lipodystrophy not taking daily Pioglitazone
Other: Observation
Participants will be observed for 16 weeks but will not receive drug

Primary Outcome Measures :
  1. Percent of liver fat pre/post challenge with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Participants must be 18 years of age or older of all racial and ethnic origins, and capable of giving informed consent. Spanish speaking individuals are eligible for participation.

Additionally they must be/have:

  1. Biologically male (not transgendered)
  2. HIV positive for at least 24 months,
  3. On stable HAART for at least the last 3 months prior to entering the study,
  4. Practitioner diagnosed lipodystrophy as defined by:

aHAL (any of these) decreased subcutaneous fat in the limbs with prominent veins, loss of buttock fat or facial atrophy hHAL: fat accumulation in abdomen and/or dorsocervical region

Exclusion Criteria:

Participants cannot be less than 18 years of age, institutionalized, nor have prior diseases or conditions that may alter body fat composition. Exclusions:

  1. Females are excluded
  2. Prior history of CHF
  3. Prior history of macular retinal edema
  4. Prior history of spontaneous bone fracture
  5. Diabetics receiving oral/injected/inhaled diabetic agents or individuals with a fasting blood glucose value greater than or equal to 140 within the last 90 days.
  6. Current active opportunistic infections for example :

    1. PCP pneumonia
    2. Neuropathy
    3. Thrush
    4. Systemic KS (Kaposi sarcoma)

    i) localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis

  7. Planning to discontinue HAART
  8. Current diagnosis of cancer or receiving chemotherapy
  9. Systemic steroid use during the prior 6 months
  10. Hepatitis C+ or previous diagnosis of cirrhosis
  11. Liver Function Studies great than or equal to triple of normal values

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01023620

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Contact: Michael Limerick, RN, PhD 214-590-8557
Contact: Minerva Santos 214-590-2794

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United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-9173
Sub-Investigator: Philipp Scherer, PhD         
Sub-Investigator: Gary Sinclair, MD         
Sub-Investigator: Mamta K Jain, MD         
Sub-Investigator: Jeffrey Browning, MD         
Sub-Investigator: Maria Ramos-Ramon, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Takeda Pharmaceuticals North America, Inc.
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Principal Investigator: Michael Limerick, RN, PhD UT Southwestern Medical Center at Dallas

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Responsible Party: Michael Limerick, RN, PhD Assistant Professor, Internal Medicine, Infectious Diseases, UT Southwestern Medical Center at Dallas Identifier: NCT01023620     History of Changes
Other Study ID Numbers: Takeda IISR - MSA-PIO-028
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Keywords provided by University of Texas Southwestern Medical Center:
Human Immunodeficiency Virus

Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs