HIV InfectionsHALNCT01023620
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
A study testing Pioglitazone and Observation in people with HIV Infections, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Pioglitazone and Observation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 31 May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Current active opportunistic infections for example :
- PCP pneumonia
- Neuropathy
- Thrush
- Systemic KS (Kaposi sarcoma)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9173
About this study
Official title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
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.
Read more
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
- Being tested
- Pioglitazone, Observation
- Keywords
- HIV, Lipodystrophy, Lipoatrophy, Lipohypertrophy, Human Immunodeficiency Virus
- Medical subject headings
- HIV Infections, Lipodystrophy, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
ObservationOther
Also called Comparison
Participants will be observed for 16 weeks but will not receive drug
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg Receives: Drug: Pioglitazone |
| Observation/Comparison | Sham comparator | 10 male patients with lipodystrophy not taking daily Pioglitazone Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2009
- Primary completion31 May 2010
- Study completion31 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy Rollins, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023620
- Sponsor's protocol ID
- Takeda IISR - MSA-PIO-028
- Acronym
- HAL
- Status last verified
- Sep 2019
- First submitted
- 30 Nov 2009
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
- ClinicalTrials.gov ID
- NCT01023620
- Acronym / sponsor ID
- HAL / Takeda IISR - MSA-PIO-028
- Conditions
- HIV Infections
- Keywords
- HIV, Lipodystrophy, Lipoatrophy, Lipohypertrophy, Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Oct 2009 (actual)
- Primary completion
- 31 May 2010 (actual)
- Study completion
- 31 May 2010 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Pioglitazone10 male patients with lipodystrophy taking daily Pioglitazone 45 mg |
| Observation/Comparison | Sham comparator | Other: Observation10 male patients with lipodystrophy not taking daily Pioglitazone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: ActosParticipants will take oral Pioglitazone 45 mg daily for 16 weeks. | Drug | Pioglitazone |
| ObservationAlso: ComparisonParticipants will be observed for 16 weeks but will not receive drug | Other | Observation/Comparison |
Primary outcome
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
1 secondary outcome
Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Rollins, MD principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone and Observation in people with HIV Infections, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.