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Completed

NCT Number: NCT01023620

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9173, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Biologically male (not transgendered)
  • HIV positive for at least 24 months,
  • On stable HAART for at least the last 3 months prior to entering the study,
  • 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:

  • Females are excluded
  • Prior history of CHF
  • Prior history of macular retinal edema
  • Prior history of spontaneous bone fracture
  • 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.
  • Current active opportunistic infections for example :
  • PCP pneumonia
  • Neuropathy
  • Thrush
  • Systemic KS (Kaposi sarcoma)

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

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

Treatment and study plan

pioglitazone

Drug

Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

Other names: Actos

observation

Other

Participants will be observed for 16 weeks but will not receive drug

Other names: Comparison

Primary outcomes

  1. Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg

    Time frame: 16 weeks

    No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed

Secondary outcomes

  1. Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

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

Acronym: HAL

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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