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Trial · NCT00367744

Rosiglitazone Effect on Mitochondria and Lipoatrophy

NCT00367744, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2017-02-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Rosiglitazone Effect on Mitochondria and Lipoatrophy. Trials, record NCT00367744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00367744

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Rosiglitazone Effect on Mitochondria and Lipoatrophy
NCT number
NCT00367744
Status
Completed
Phases
Phase 2
Enrollment
71 participants, actual
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
HIV Infections
Interventions
Rosiglitazone, Placebo
First posted
2006-08-23
Last updated
2017-02-06
Results first posted
2017-02-06
Limitations and caveats
Limitations of the study include a relative small sample size as well as loss of follow up of 9 participants at the end of the study.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Limb Fat at 48 Weeks48 weeksLimb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Secondarythe Change in the Carotid IMT of the Common Carotid Artery48 weeksCarotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Limb Fat at 48 Weeks48 weeksIntention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.gramsMEDIAN
SECONDARYthe Change in the Carotid IMT of the Common Carotid Artery48 weeksIntention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was availablemmMEDIAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Limb Fat at 48 WeeksRosiglitazone448Inter-Quartile Range 138 to 1670grams
Change in Limb Fat at 48 WeeksPlacebo153Inter-Quartile Range -100 to 682grams
the Change in the Carotid IMT of the Common Carotid ArteryRosiglitazone0.10Inter-Quartile Range -0.05 to 0.25mm
the Change in the Carotid IMT of the Common Carotid ArteryPlacebo0.15Inter-Quartile Range 0 to 0.25mm

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDRosiglitazone34
Overall StudySTARTEDPlacebo37
Overall StudyCOMPLETEDRosiglitazone30
Overall StudyCOMPLETEDPlacebo32
Overall StudyNOT COMPLETEDRosiglitazone4
Overall StudyNOT COMPLETEDPlacebo5

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherLow Fasting Glucose (Grade 1)Metabolism and nutrition disordersRosiglitazone134
otherLow Fasting Glucose (Grade 1)Metabolism and nutrition disordersPlacebo037
otherLow Phosphate (Grade 2)Musculoskeletal and connective tissue disordersRosiglitazone534
otherLow Phosphate (Grade 2)Musculoskeletal and connective tissue disordersPlacebo537
otherElevated Bilirubin (Grade 2 or 3)Blood and lymphatic system disordersRosiglitazone034
otherElevated Bilirubin (Grade 2 or 3)Blood and lymphatic system disordersPlacebo137
otherElevated Creatine Kinase (Grade 2)Musculoskeletal and connective tissue disordersRosiglitazone034
otherElevated Creatine Kinase (Grade 2)Musculoskeletal and connective tissue disordersPlacebo137
seriousElevated Cholesterol (Grade 2 or 3)Cardiac disordersRosiglitazone434
seriousElevated Cholesterol (Grade 2 or 3)Cardiac disordersPlacebo637

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityRosiglitazone
Total, all-cause mortalityPlacebo
Total, other adverse eventsRosiglitazone634
Total, other adverse eventsPlacebo737
Total, serious adverse eventsRosiglitazone1534
Total, serious adverse eventsPlacebo1337

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
20453626DERIVEDPubMed
20969457DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Rosiglitazone vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00367744

GET https://conductscience.org/api/trials/v1/NCT00367744/events?page=2