HIV InfectionsPhase 4NCT00192621
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
A Phase 4 study testing Combivir (zidovudine [AZT] / lamivudine [3TC]) and Kaletra (lopinavir [LPVr]) in people with HIV Infections and Dyslipidemias, run by Kirby Institute at 1 site in Australia.
Trial summary
This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Dyslipidemias, Glucose Metabolism Disorders
- What is being tested?
- Combivir (zidovudine [AZT] / lamivudine [3TC]) and Kaletra (lopinavir [LPVr])
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2004to Dec 2006
- 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 negative and HIV DNA negative at time of entry to the study.
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.
- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication.
- Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
- Alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
- Prior use of any retinoid-containing compound within the previous six months.
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- Abnormal coagulation.
- Previous allergic reaction or known allergy to local anaesthetic.
- Previous use of psychotropic medications.
- Concomitant use of medications, including those metabolised by CYP3A4 enzyme system, 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.
- Any grade-two 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.
- Gastrointestinal disorders, which may affect drug absorption.
- 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
- Evidence of acute or chronic active hepatitis B virus infection by serology performed at baseline.
- Evidence of hepatitis C infection by serology performed at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism
This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects.
Read the detailed description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in the way that fat is laid down on the body. This results in fat loss from some parts of the body, with fat deposits at other sites, giving a characteristic look known as "HIV associated lipodystrophy" or HIVLD. With these changes, there are also abnormalities in glucose and fat metabolism (collectively termed metabolic abnormalities). In HIV negative populations, these metabolic changes are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to investigate if changes in the body's handling of fats and glucose occur with a short course of treatment in HIV negative subjects and if these correlate to an increased risk of CVD.
- Conditions
- HIV Infections, Dyslipidemias, Glucose Metabolism Disorders, Metabolic Diseases, Lipodystrophy, Cardiovascular Disease
- Being tested
- Combivir (zidovudine [AZT] / lamivudine [3TC]), Kaletra (lopinavir [LPVr])
- Keywords
- HIV negative healthy subjects, Lipid metabolism, Glucose metabolism, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, HIV
- Medical subject headings
- HIV Infections, Dyslipidemias, Glucose Metabolism Disorders, Metabolic Diseases, Lipodystrophy, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combivir (zidovudine [AZT] / lamivudine [3TC])Drug
Kaletra (lopinavir [LPVr])Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine effect of 6 wks ART with LPVr and CBV, alone and in combination, in HIV negative healthy subjects with respect to changes from baseline in genes related to mitochondrial and lipid metabolism in adipocytes
Secondary outcomes (1)
includes: To determine the effect of 6 wks of ART with LPVr and CBV in HIV negative subjects with respect to: changes from baseline in genes related to mitochondrial and lipid and glucose metabolism in monocytes.
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 startNov 2004
- Primary completionDec 2006
- Study completionDec 2006
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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), Garvan Institute of Medical Research, Prince of Wales Hospital, Sydney
- Responsible party
- Sponsor
- Investigators
- Andrew D Carr, MD, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.David A Cooper, MD, Study director, National Centre in HIV Epidemiology and Clinical Research.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192621
- Sponsor's protocol ID
- SAMA 002 Version 5
- Other IDs
- ACTR012605000661673
- 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
- A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT00192621
- Acronym / sponsor ID
- SAMA 002 Version 5
- Conditions
- HIV Infections, Dyslipidemias, Glucose Metabolism Disorders, Metabolic Diseases, Lipodystrophy, Cardiovascular Disease
- Keywords
- HIV negative healthy subjects, Lipid metabolism, Glucose metabolism, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- St Vincent's Hospital, Sydney, National Heart, Lung, and Blood Institute (NHLBI), Garvan Institute of Medical Research, Prince of Wales Hospital, Sydney
- Study start
- Nov 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (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 randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects.
Detailed description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in the way that fat is laid down on the body. This results in fat loss from some parts of the body, with fat deposits at other sites, giving a characteristic look known as "HIV associated lipodystrophy" or HIVLD. With these changes, there are also abnormalities in glucose and fat metabolism (collectively termed metabolic abnormalities). In HIV negative populations, these metabolic changes are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to investigate if changes in the body's handling of fats and glucose occur with a short course of treatment in HIV negative subjects and if these correlate to an increased risk of CVD.
Study design
- Primary purpose
- Basic science
- 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 (3 listed)
- Age >18
- Be able to provide written consent to perform in the trial.
- HIV antibody negative and HIV DNA negative at time of entry to the study.
Key exclusion criteria (17 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.
- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication.
- Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
- Alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
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 |
|---|---|---|
| Combivir (zidovudine [AZT] / lamivudine [3TC]) | Drug | – |
| Kaletra (lopinavir [LPVr]) | Drug | – |
Primary outcome
To determine effect of 6 wks ART with LPVr and CBV, alone and in combination, in HIV negative healthy subjects with respect to changes from baseline in genes related to mitochondrial and lipid metabolism in adipocytes
1 secondary outcome
includes: To determine the effect of 6 wks of ART with LPVr and CBV in HIV negative subjects with respect to: changes from baseline in genes related to mitochondrial and lipid and glucose metabolism in monocytes.
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.
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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.
Andrew D Carr, MD principal investigator
National Centre in HIV Epidemiology and Clinical Research.
David A Cooper, MD study director
National Centre in HIV Epidemiology and Clinical Research.
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 Combivir (zidovudine [AZT] / lamivudine [3TC]) and Kaletra (lopinavir [LPVr]) in people with HIV Infections and Dyslipidemias, 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 3 inclusion and 17 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 determine effect of 6 wks ART with LPVr and CBV, alone and in combination, in HIV negative healthy subjects with respect to changes from baseline in genes related to mitochondrial and lipid metabolism in adipocytes. 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; AzTrials last refreshed its copy on 1 Nov 2026.