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NCT01023620 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
4
Enrollment target

NCT01023620: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT01023620 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01023620, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
4 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • OTHER Observation
  • DRUG Pioglitazone

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2009-10
Est. Completion 2010-05-31
Phase NA

What the finished NCT01023620 record still lists

NCT01023620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.

NCT01023620 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01023620 about?

NCT01023620 is a clinical study titled "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 (s...

What is the current status of trial NCT01023620?

This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2009-10. Estimated completion is 2010-05-31.

What interventions are being tested in trial NCT01023620?

The interventions under investigation include: Observation (OTHER), Pioglitazone (DRUG).

Who is sponsoring clinical trial NCT01023620?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01023620's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01023620, the US trial registry maintained by the National Library of Medicine. NCT01023620 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.