HIV InfectionsPhase 2NCT00367744

Rosiglitazone Effect on Mitochondria and Lipoatrophy

A Phase 2 study testing Rosiglitazone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Rosiglitazone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 2 sitesUnited States
Study dates: Jul 2006to Dec 2008
Phase: Phase 2
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Lipoatrophy
Thymidine sparing ARV for at least 24 weeks
Prior thymidine NRTIs for at least 12 months

Who cannot join

Diabetes
Heart failure
Liver disease
Hormonal therapies

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cleveland Clinc Foundation
Cleveland, Ohio, 44106
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, 44141

Other trials in United States

About this study

Official title: Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy

Read the detailed description

This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Conditions: HIV Infections
Being tested: Rosiglitazone, Placebo
Keywords: mitochondria, HIV, lipoatrophy
Medical subject headings: HIV Infections, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosiglitazoneDrug
Also called Glitazones, avandia
Rosiglitazone 4mg BID
PlaceboDrug
Placebo for rosiglitazone

Study groups in NCT00367744
Study group	Role	What they receive
Rosigitazone arm	Active comparator	Rosiglitazone active 4 mg BID Receives: Drug: Rosiglitazone
Placebo arm	Placebo comparator	Matching Placebo BID Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Limb Fat at 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.
Measured: 48 weeks

Secondary outcomes (1)

the Change in the Carotid IMT of the Common Carotid Artery
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.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Dec 2008

First posted23 Aug 2006 (estimated)
Study startJul 2006
Primary completionDec 2008
Study completionDec 2008

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00367744
Sponsor's protocol ID: AI060484-02-C
Other IDs: AI060484-C
Status last verified: Aug 2006
First submitted: 21 Aug 2006
Last updated: 6 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Tungsiripat M, El-Bejjani D, Rizk N, Dogra V, O'Riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Carotid intima media thickness, inflammatory markers, and endothelial activation markers in HIV Patients with lipoatrophy increased at 48 weeks regardless of use of rosiglitazone or placebo. AIDS Res Hum Retroviruses. 2011 Mar;27(3):295-302. doi: 10.1089/aid.2010.0187. Epub 2010 Oct 23.
PubMed 20969457
Tungsiripat M, Bejjani DE, Rizk N, O'riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Rosiglitazone improves lipoatrophy in patients receiving thymidine-sparing regimens. AIDS. 2010 Jun 1;24(9):1291-8. doi: 10.1097/QAD.0b013e328339e274.
PubMed 20453626

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
ClinicalTrials.gov ID: NCT00367744
Acronym / sponsor ID: AI060484-02-C
Conditions: HIV Infections
Keywords: mitochondria, HIV, lipoatrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: GlaxoSmithKline
Study start: Jul 2006
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 23 Aug 2006 (estimated)
Results: Posted 6 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Rosigitazone arm	Active comparator	Drug: RosiglitazoneRosiglitazone active 4 mg BID
Placebo arm	Placebo comparator	Drug: PlaceboMatching Placebo BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Lipoatrophy
Thymidine sparing ARV for at least 24 weeks
Prior thymidine NRTIs for at least 12 months

Key exclusion criteria (4 listed)

Diabetes
Heart failure
Liver disease
Hormonal therapies

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
RosiglitazoneAlso: Glitazones, avandiaRosiglitazone 4mg BID	Drug	Rosigitazone arm
PlaceboPlacebo for rosiglitazone	Drug	Placebo arm

Primary outcome

Change in Limb Fat at 48 Weeks
Time frame: 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.

1 secondary outcome

the Change in the Carotid IMT of the Common Carotid Artery
Time frame: 48 weeks

Results and safety

Results posted to the registry on 6 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosiglitazone	34	30
Placebo	37	32

Primary outcome: Change in Limb Fat at 48 Weeks

Time frame: 48 weeks. Median (Inter-Quartile Range). Unit: grams

Measure	Rosiglitazone n = 34	Placebo n = 37
Value	448 (138 to 1670)	153 (-100 to 682)

Rosiglitazone vs Placebo: p = 0.02, Wilcoxon (Mann-Whitney)

Population analysed: Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: weeks 2,4,12,18,24,36 and 48. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosiglitazone	15 of 34 (44.1%)	6 of 34 (17.6%)	Not reported
Placebo	13 of 37 (35.1%)	7 of 37 (18.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20969457Tungsiripat M, El-Bejjani D, Rizk N, Dogra V, O'Riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Carotid intima media thickness, inflammatory markers, and endothelial activation markers in HIV Patients with lipoatrophy increased at 48 weeks regardless of use of rosiglitazone or placebo. AIDS Res Hum Retroviruses. 2011 Mar;27(3):295-302. doi: 10.1089/aid.2010.0187. Epub 2010 Oct 23.
Derived from this study: PubMed 20453626Tungsiripat M, Bejjani DE, Rizk N, O'riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Rosiglitazone improves lipoatrophy in patients receiving thymidine-sparing regimens. AIDS. 2010 Jun 1;24(9):1291-8. doi: 10.1097/QAD.0b013e328339e274.
to find more about rosiglitazone effectiveness on LipoatrophyLink provided by the sponsor.
Individual participant dataSharing planned: No

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Enrolling by invitation
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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.

Grace McComsey principal investigator

Case Western Reserve University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosiglitazone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 3 inclusion and 4 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2017). 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?

Change in Limb Fat at 48 Weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00367744, which also lists 2 linked publications.

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 6 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.