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

NCT ID: NCT01023620

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-05-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pioglitazone

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

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

Observation/Comparison

10 male patients with lipodystrophy not taking daily Pioglitazone

Group Type: SHAM_COMPARATOR

Observation

Intervention Type: OTHER

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

Interventions

Pioglitazone

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

Intervention Type: DRUG

Observation

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

Intervention Type: OTHER

Other Intervention Names

Actos; Comparison

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Rollins, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

Locations

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

Takeda IISR - MSA-PIO-028

Identifier Type: -

Identifier Source: org_study_id