HIV-Associated Lipodystrophy SyndromePhase 4NCT00135460
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
A Phase 4 study testing nucleoside analogue sparing HAART regimen in people with HIV-Associated Lipodystrophy Syndrome, run by Danish HIV Research Group at 5 sites in Denmark.
Trial summary
Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Associated Lipodystrophy Syndrome
- What is being tested?
- nucleoside analogue sparing HAART regimen
- How many people
- 100 participants
- Where
- 5 sitesDenmark
- Study dates
- Jun 2003to Nov 2007
- 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
- Antiretroviral naïve patients
- HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
- Fulfilling the criteria for starting antiretroviral therapy.
- Ability to understand and provide written informed consent.
Who cannot join
- Women being pregnant or breast-feeding.
- Fertile women using no safe contraception.
- Patients with active intravenous drug use.
- Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
- Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.
- Creatinine > 200 mmol/l.
- ALT or AST > 5 times upper normal value (200U/l).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Infectious Diseases, Aalborg Hospital
Aalborg
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, 8200
Department of Infectious Diseases, Rigshospitalet
Copenhagen, 2100
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
Department of Infectious Diseases, Odense University Hospital
Odense, 5000
About this study
Official title: Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.
Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.
There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.
Read more
The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.
The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Being tested
- nucleoside analogue sparing HAART regimen
- Keywords
- HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, Lipodystrophy, HIV Infections, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nucleoside analogue sparing HAART regimenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral fat mass, determined by DEXA-changes
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Change from baseline in fasting lipids and subsets hereof
Development of impaired glucose tolerance and insulin resistance
Secondary outcomes (10)
Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
Incidence of adverse events
Incidence of clinical disease progression
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Change in plasma lactate from baseline
Time to discontinuation of the randomized therapy and reasons for this
Incidence of genotypical and virological resistance
Development of osteopenia, judged by DEXA-scan
Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startJun 2003
- Study completionNov 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Danish HIV Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Abbott
- Investigators
- Jan Gerstoft, M.D., DMSc, Study chair, Copenhagen University Hospital, RigshospitaletNiels Obel, M.D., DMSc, Principal investigator, Odense University HospitalCourt Pedersen, Professor, Principal investigator, Odense University HospitalLars Mathiesen, M.D.,DMSc, Principal investigator, Hvidovre University HospitalHenrik Nielsen, M.D.,DMSc, Principal investigator, Aalborg University HospitalAlex Laursen, M.D., DMSc, Principal investigator, Aarhus University CityAnn-Brit E Hansen, M.D., Principal investigator, Copenhagen University Hospital Rigshospitalet and Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135460
- Sponsor's protocol ID
- 2612-2198
- Status last verified
- Sep 2005
- First submitted
- 25 Aug 2005
- Last updated
- 14 Mar 2006
- Results posted
- No
Publications
Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.
PubMed 28399815
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.
- ClinicalTrials.gov ID
- NCT00135460
- Acronym / sponsor ID
- 2612-2198
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Keywords
- HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Danish HIV Research GroupUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Abbott
- Study start
- Jun 2003
- Study completion
- Nov 2007
- First posted
- 26 Aug 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.
Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.
There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.
The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.
The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.
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 (4 listed)
- Antiretroviral naïve patients
- HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
- Fulfilling the criteria for starting antiretroviral therapy.
- Ability to understand and provide written informed consent.
Key exclusion criteria (7 listed)
- Women being pregnant or breast-feeding.
- Fertile women using no safe contraception.
- Patients with active intravenous drug use.
- Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
- Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.
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 |
|---|---|---|
| nucleoside analogue sparing HAART regimen | Drug | – |
Primary outcome
Changes in peripheral fat mass, determined by DEXA-changes
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Change from baseline in fasting lipids and subsets hereof
Development of impaired glucose tolerance and insulin resistance
10 secondary outcomes
Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
Incidence of adverse events
Incidence of clinical disease progression
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Change in plasma lactate from baseline
Time to discontinuation of the randomized therapy and reasons for this
Incidence of genotypical and virological resistance
Development of osteopenia, judged by DEXA-scan
Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2006.
- Derived from this study: PubMed 28399815Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.
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.
Jan Gerstoft, M.D., DMSc study chair
Copenhagen University Hospital, Rigshospitalet
Niels Obel, M.D., DMSc principal investigator
Odense University Hospital
Court Pedersen, Professor principal investigator
Odense University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nucleoside analogue sparing HAART regimen in people with HIV-Associated Lipodystrophy Syndrome, run by Danish HIV Research Group at 5 sites in Denmark.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
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?
Changes in peripheral fat mass, determined by DEXA-changes. The study lists 4 primary outcomes in all. 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 NCT00135460, 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 14 Mar 2006.