NCT01023620: HAL

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

Completed NA Results posted Last updated 16 September 2019

What this trial tests

NA trial testing Pioglitazone in HIV Infections in 4 participants. Completed in 31 May 2010.

Timeline

1 October 2009

Primary endpoint
31 May 2010

31 May 2010

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	4
Start date	1 October 2009
Primary completion	31 May 2010
Estimated completion	31 May 2010
Sites	1 location across United States

Drugs / interventions tested

• Pioglitazone (pioglitazone) — full drug profile →
• Observation

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An approach for transgender population information extraction and summarization from clinical trial text.
   Chen B, Jin H, Yang Z, Qu Y, et al · · 2019 · cited 9× · PMID 30961595 · DOI 10.1186/s12911-019-0768-1