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Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified December 2009

Sponsor
University of Texas Southwestern Medical Center

Collaborator
Takeda Pharmaceuticals North America, Inc.

Information provided by (Responsible Party)
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier
NCT01023620

First received: November 30, 2009
Last updated: December 1, 2009
Last Verified: December 2009
History of Changes
Purpose

Purpose

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 Intervention
HIV Infections

Drug : Pioglitazone
Other : Observation

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures

  • Percent of liver fat pre/post challenge with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ]
Secondary Outcome Measures:
  • Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ]

Estimated Enrollment: 24
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

Criteria

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

    contacts and locations

    Contacts and Locations

    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, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT01023620

    Contacts

    Contact:   Michael Limerick, RN, PhD 214-590-8557 Michael.Limerick@utsouthwestern.edu
    Contact:   Minerva Santos 214-590-2794 Minerva.Santos@UTSouthwestern.edu

    Locations

    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.

    Investigators

    Principal Investigator: Michael Limerick, RN, PhD UT Southwestern Medical Center at Dallas
    More Information

    More Information


    Responsible Party: Michael Limerick, RN, PhD Assistant Professor, Internal Medicine, Infectious Diseases, UT Southwestern Medical Center at Dallas  
    ClinicalTrials.gov Identifier: NCT01023620   History of Changes  
    Other Study ID Numbers: Takeda IISR - MSA-PIO-028  
    Study First Received: November 30, 2009  
    Last Updated: December 1, 2009  

    Keywords provided by University of Texas Southwestern Medical Center:

    HIV
    Lipodystrophy
    Lipoatrophy
    Lipohypertrophy
    Human Immunodeficiency Virus

    Additional relevant MeSH terms:
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Lipodystrophy
    Pioglitazone
    2,4-thiazolidinedione

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.