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

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pioglitazone

Observation

About this trial

This is an interventional other trial for HIV Infections focused on measuring HIV, Lipodystrophy, Lipoatrophy, Lipohypertrophy, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 :
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
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

Sites / Locations

UT Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pioglitazone

Observation/Comparison

Arm Description

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

10 male patients with lipodystrophy not taking daily Pioglitazone

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

Full Information

NCT ID

NCT01023620

First Posted

November 30, 2009

Last Updated

September 16, 2019

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Takeda Pharmaceuticals North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01023620

Brief Title

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

Acronym

HAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

October 2009 (Actual)

Primary Completion Date

May 31, 2010 (Actual)

Study Completion Date

May 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, Lipodystrophy, Lipoatrophy, Lipohypertrophy, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone

Arm Type

Experimental

Arm Description

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Arm Title

Observation/Comparison

Arm Type

Sham Comparator

Arm Description

10 male patients with lipodystrophy not taking daily Pioglitazone

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Other Intervention Name(s)

Actos

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Observation

Other Intervention Name(s)

Comparison

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

16 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Biological Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Rollins, MD

Organizational Affiliation

UT Southwestern Medical Center at Dallas

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9173

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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