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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01023620
First received: November 30, 2009
Last updated: December 1, 2009
Last verified: December 2009

November 30, 2009
December 1, 2009
October 2009
December 2010   (final data collection date for primary outcome measure)
Percent of liver fat pre/post challenge with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01023620 on ClinicalTrials.gov Archive Site
Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Pioglitazone
    Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
  • Other: Observation
    Participants will be observed for 16 weeks but will not receive drug
  • Experimental: Pioglitazone
    10 male patients with lipodystrophy taking daily Pioglitazone 45 mg
    Intervention: Drug: Pioglitazone
  • No Intervention: Observation/Comparison
    10 male patients with lipodystrophy not taking daily Pioglitazone
    Intervention: Other: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Michael Limerick, RN, PhD 214-590-8557 Michael.Limerick@utsouthwestern.edu
Contact: Minerva Santos 214-590-2794 Minerva.Santos@UTSouthwestern.edu
United States
 
NCT01023620
Takeda IISR - MSA-PIO-028
Yes
Michael Limerick, RN, PhD Assistant Professor, Internal Medicine, Infectious Diseases, UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Michael Limerick, RN, PhD UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP