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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental | 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg |
|
| Observation/Comparison | Sham Comparator | 10 male patients with lipodystrophy not taking daily Pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Participants will take oral Pioglitazone 45 mg daily for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg | 16 weeks |
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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:
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 :
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
Biological Male
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Rollins, MD | UT Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390-9173 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks. |
| FG001 | Observation/Comparison | 10 male patients with lipodystrophy not taking daily Pioglitazone Observation: Participants will be observed for 16 weeks but will not receive drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks. |
| BG001 | Observation/Comparison |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Posted | 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
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Limerick | UT Southwestern Medical Center | 214-590-0611 | Michael.Limerick@UTSouthwestern.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D019370 | Observation |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Observation | Other | Participants will be observed for 16 weeks but will not receive drug |
|
|
10 male patients with lipodystrophy not taking daily Pioglitazone
Observation: Participants will be observed for 16 weeks but will not receive drug
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| 0 Participants |
|
| Secondary | Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg | Investigator left the university mid way through the study and unable to find him. | Posted | 16 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Observation/Comparison | 10 male patients with lipodystrophy not taking daily Pioglitazone Observation: Participants will be observed for 16 weeks but will not receive drug | 0 | 0 | 0 | 0 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012897 | Slow Virus Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008722 | Methods |
| D008919 | Investigative Techniques |