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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Limb Fat at 48 Weeks | 48 weeks | Limb 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. |
| Secondary | the Change in the Carotid IMT of the Common Carotid Artery | 48 weeks | Carotid 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Limb Fat at 48 Weeks | 48 weeks | Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble. | grams | MEDIAN |
| SECONDARY | the Change in the Carotid IMT of the Common Carotid Artery | 48 weeks | Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available | mm | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Limb Fat at 48 Weeks | Rosiglitazone | 448 | Inter-Quartile Range 138 to 1670 | grams | |
| Change in Limb Fat at 48 Weeks | Placebo | 153 | Inter-Quartile Range -100 to 682 | grams | |
| the Change in the Carotid IMT of the Common Carotid Artery | Rosiglitazone | 0.10 | Inter-Quartile Range -0.05 to 0.25 | mm | |
| the Change in the Carotid IMT of the Common Carotid Artery | Placebo | 0.15 | Inter-Quartile Range 0 to 0.25 | mm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosiglitazone | 34 | |
| Overall Study | STARTED | Placebo | 37 | |
| Overall Study | COMPLETED | Rosiglitazone | 30 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Rosiglitazone | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Low Fasting Glucose (Grade 1) | Metabolism and nutrition disorders | Rosiglitazone | 1 | 34 | |
| other | Low Fasting Glucose (Grade 1) | Metabolism and nutrition disorders | Placebo | 0 | 37 | |
| other | Low Phosphate (Grade 2) | Musculoskeletal and connective tissue disorders | Rosiglitazone | 5 | 34 | |
| other | Low Phosphate (Grade 2) | Musculoskeletal and connective tissue disorders | Placebo | 5 | 37 | |
| other | Elevated Bilirubin (Grade 2 or 3) | Blood and lymphatic system disorders | Rosiglitazone | 0 | 34 | |
| other | Elevated Bilirubin (Grade 2 or 3) | Blood and lymphatic system disorders | Placebo | 1 | 37 | |
| other | Elevated Creatine Kinase (Grade 2) | Musculoskeletal and connective tissue disorders | Rosiglitazone | 0 | 34 | |
| other | Elevated Creatine Kinase (Grade 2) | Musculoskeletal and connective tissue disorders | Placebo | 1 | 37 | |
| serious | Elevated Cholesterol (Grade 2 or 3) | Cardiac disorders | Rosiglitazone | 4 | 34 | |
| serious | Elevated Cholesterol (Grade 2 or 3) | Cardiac disorders | Placebo | 6 | 37 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosiglitazone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rosiglitazone | 6 | 34 |
| Total, other adverse events | Placebo | 7 | 37 |
| Total, serious adverse events | Rosiglitazone | 15 | 34 |
| Total, serious adverse events | Placebo | 13 | 37 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
Source Trial comparisons
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.
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