HIV InfectionsPhase 4NCT00122655
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
A Phase 4 study testing non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitors in people with HIV Infections and HIV Lipodystrophy Syndrome, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. Maintenance of virological suppression and immunological factors are also assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV Lipodystrophy Syndrome
- What is being tested?
- non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitors
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to Jun 2005
- Phase
- Phase 4
- 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
- Males and non-pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months
- Viral load below 400 copies/ml
- Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
Who cannot join
- Current antiretroviral therapy with 3 classes of antiretroviral therapy
- Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
- Intolerance to nevirapine and efavirenz
- Acute opportunistic infection
- Diabetes
- Transaminase levels over 5 times above the upper normal limit
Show all 9Show fewer
- Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy
- Ongoing immunotherapy including interleukin-2 (IL-2) and interferon
- Pregnancy or planned pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, 75013
About this study
Official title: A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression.
Maintenance of virological suppression and immunological factors are also assessed.
Read the detailed description
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.
- Conditions
- HIV Infections, HIV Lipodystrophy Syndrome
- Being tested
- non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, protease inhibitors
- Keywords
- HIV infections, HIV Lipodystrophy Syndrome
- Medical subject headings
- HIV Infections, HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-nucleoside reverse transcriptase inhibitorsDrug
nucleoside reverse transcriptase inhibitorsDrug
protease inhibitorsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
Secondary outcomes (4)
Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
Change in CD4 cell count between day 0 (D0) and week 48
Change in lipid profile and glucidic metabolism between D0 and week 48
Evolution of SAT/TAT and VAT/TAT between D0 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2001
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Investigators
- Marc Antoine Valantin, MD, Principal investigator, Service des Maladies Infectieuses Hopital Pitie-Salpetriere ParisDominique Costagliola, Study chair, INSERM U720
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122655
- Sponsor's protocol ID
- ANRS108 NONUKE
- Status last verified
- Nov 2005
- First submitted
- 21 Jul 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study
- ClinicalTrials.gov ID
- NCT00122655
- Acronym / sponsor ID
- ANRS108 NONUKE
- Conditions
- HIV Infections, HIV Lipodystrophy Syndrome
- Keywords
- HIV infections, HIV Lipodystrophy Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jan 2001
- Study completion
- Jun 2005
- First posted
- 22 Jul 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 trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression.
Maintenance of virological suppression and immunological factors are also assessed.
Detailed description
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and non-pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months
- Viral load below 400 copies/ml
- Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
Key exclusion criteria (9 listed)
- Current antiretroviral therapy with 3 classes of antiretroviral therapy
- Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
- Intolerance to nevirapine and efavirenz
- Acute opportunistic infection
- Diabetes
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 |
|---|---|---|
| non-nucleoside reverse transcriptase inhibitors | Drug | – |
| nucleoside reverse transcriptase inhibitors | Drug | – |
| protease inhibitors | Drug | – |
Primary outcome
Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
4 secondary outcomes
Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
Change in CD4 cell count between day 0 (D0) and week 48
Change in lipid profile and glucidic metabolism between D0 and week 48
Evolution of SAT/TAT and VAT/TAT between D0 and week 48
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 15 Nov 2005.
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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.
Marc Antoine Valantin, MD principal investigator
Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris
Dominique Costagliola study chair
INSERM U720
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitors in people with HIV Infections and HIV Lipodystrophy Syndrome, 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 5 inclusion and 9 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 15 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2005.