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
  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: Open Label
Official Title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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
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
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014