HIV-Associated Lipodystrophy SyndromePhase 3NCT00148850
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
A Phase 3 study testing Pioglitazone in people with HIV-Associated Lipodystrophy Syndrome and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Associated Lipodystrophy Syndrome, HIV Infections
- What is being tested?
- Pioglitazone
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2003to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 years of ages and older
- Confirmed laboratory diagnosis of HIV-1-infection
- Karnofsky equal or over 70%
- Patients treated with stable antiretroviral therapy for at least 6 months
- Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months
- Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination
Who cannot join
- Cachexia
- Cardiac failure class3 or 4 at NYHA classification
- Acute opportunistic infection
- Pregnancy or breast-feeding
- Polynuclear neutrophils below 1000/mm3
- Hemoglobin below 9 g/dl
Show all 12Show fewer
- Platelets below 50 000/mm3
- Creatinine level over 2 UN
- ASAT, ALAT over 2.5UN
- Bilirubin, amylase, lipase level over 2 UN
- CD4 count below 200/mm3
- Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, 75020
About this study
Official title: A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.
Read the detailed description
Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.
Different previous studies were performed with that aim, most of them using rosiglitazone.
We designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.
- Being tested
- Pioglitazone
- Keywords
- HIV-Associated Lipodystrophy Syndrome, pioglitazone, HIV infections, Treatment Experienced
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
Secondary outcomes (6)
Changes from inclusion to week 48:
Lipid profile and the glucidic metabolism
SAT/TAT and VAT/TAT ratios evaluated with scanner
X ray of L4
Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
Evaluation of clinical and biological safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-Associated Lipodystrophy SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Takeda
- Investigators
- Willy Rozenbaum, MD, Principal investigator, Hopital Tenon ParisDominique Costagliola, Study chair, INSERM U 720
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148850
- Sponsor's protocol ID
- ANRS 113 LIPIOT
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 20 Oct 2005
- Results posted
- No
Publications
Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.
PubMed 18389900
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study
- ClinicalTrials.gov ID
- NCT00148850
- Acronym / sponsor ID
- ANRS 113 LIPIOT
- Keywords
- HIV-Associated Lipodystrophy Syndrome, pioglitazone, HIV infections, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Takeda
- Study start
- Feb 2003
- Study completion
- Oct 2004
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.
Detailed description
Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.
Different previous studies were performed with that aim, most of them using rosiglitazone.
We designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of ages and older
- Confirmed laboratory diagnosis of HIV-1-infection
- Karnofsky equal or over 70%
- Patients treated with stable antiretroviral therapy for at least 6 months
- Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months
Key exclusion criteria (12 listed)
- Cachexia
- Cardiac failure class3 or 4 at NYHA classification
- Acute opportunistic infection
- Pregnancy or breast-feeding
- Polynuclear neutrophils below 1000/mm3
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 |
|---|---|---|
| Pioglitazone | Drug | – |
Primary outcome
Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
6 secondary outcomes
Changes from inclusion to week 48:
Lipid profile and the glucidic metabolism
SAT/TAT and VAT/TAT ratios evaluated with scanner
X ray of L4
Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
Evaluation of clinical and biological safety
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2005.
- Derived from this study: PubMed 18389900Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.
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.
Willy Rozenbaum, MD principal investigator
Hopital Tenon Paris
Dominique Costagliola study chair
INSERM U 720
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone in people with HIV-Associated Lipodystrophy Syndrome and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry). 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 NCT00148850, which also lists 1 linked publication.
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 20 Oct 2005.