HIV-Associated Lipodystrophy SyndromePhase 4NCT00192660
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
A Phase 4 study testing Lamivudine, Stavudine and Didanosine in people with HIV-Associated Lipodystrophy Syndrome and Cardiovascular Disease, run by Kirby Institute at 1 site in Australia.
Trial summary
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-Associated Lipodystrophy Syndrome, Cardiovascular Disease
- What is being tested?
- Lamivudine, Stavudine and Didanosine
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2003to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18.
- Be able to provide written consent to perform in the trial.
- HIV antibody positive at time of entry to the study.
- Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (HAMA) part A only:
- Be naive to antiretroviral medication.
- Specific to HAMA part B only:
- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
- Have had a minimum of 48 weeks interval since completion of HAMA part A.
Who cannot join
- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
- Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
- Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
- Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
- Prior use of any retinoid-containing compound within the previous six months.
- Abnormal coagulation.
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- Previous allergic reaction or known allergy to local anaesthetic.
- Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
- Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
- Pregnancy
- Specific to HAMA part A only:
- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
Read the detailed description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.
- Being tested
- Lamivudine, Stavudine, Didanosine, Zidovudine, Tenofovir
- Keywords
- HIV, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, Treatment Experienced, HIV Infections
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, Cardiovascular Diseases, Lipodystrophy, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
StavudineDrug
DidanosineDrug
ZidovudineDrug
TenofovirDrug
AbacavirDrug
Efavirenz (EFV)Drug
NevirapineDrug
IndinavirDrug
SaquinavirDrug
AmprenavirDrug
RitonavirDrug
NelfinavirDrug
TipranavirDrug
enfuvirtide (T20)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy
Secondary outcomes (3)
To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy
To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionOct 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- St Vincent's Hospital, Sydney, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Andrew D Carr, MD, Principal investigator, St. Vincents Hospital Sydney LimitedDavid A Cooper, MD, Study director, The National Centre in HIV Epidemiology and Clinical Research, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192660
- Sponsor's protocol ID
- HAMA 001 Version 6
- Other IDs
- R01HL065953-01
- Status last verified
- Apr 2012
- First submitted
- 12 Sep 2005
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time
- ClinicalTrials.gov ID
- NCT00192660
- Acronym / sponsor ID
- HAMA 001 Version 6
- Keywords
- HIV, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, Treatment Experienced, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- St Vincent's Hospital, Sydney, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 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.
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
Detailed description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18.
- Be able to provide written consent to perform in the trial.
- HIV antibody positive at time of entry to the study.
- Be naive to antiretroviral medication.
- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
Key exclusion criteria (13 listed)
- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
- Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
- Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
- Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
- Prior use of any retinoid-containing compound within the previous six months.
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 |
|---|---|---|
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
| Didanosine | Drug | – |
| Zidovudine | Drug | – |
| Tenofovir | Drug | – |
| Abacavir | Drug | – |
| Efavirenz (EFV) | Drug | – |
| Nevirapine | Drug | – |
| Indinavir | Drug | – |
| Saquinavir | Drug | – |
| Amprenavir | Drug | – |
| Ritonavir | Drug | – |
| Nelfinavir | Drug | – |
| Tipranavir | Drug | – |
| enfuvirtide (T20) | Drug | – |
Primary outcome
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy
3 secondary outcomes
To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy
To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- National Centre in HIV Epidemiology and Clinical Research HomepageLink provided by the sponsor.
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.
Andrew D Carr, MD principal investigator
St. Vincents Hospital Sydney Limited
David A Cooper, MD study director
The National Centre in HIV Epidemiology and Clinical Research, Sydney
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 Lamivudine, Stavudine and Didanosine in people with HIV-Associated Lipodystrophy Syndrome and Cardiovascular Disease, run by Kirby Institute at 1 site in Australia.
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 8 inclusion and 13 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 12 Apr 2012. 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy. 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 12 Apr 2012.