Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir┬« in HIV-Negative Healthy Subjects
Information source: The National Centre in HIV Epidemiology and Clinical Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Dyslipidemias; Glucose Metabolism Disorders; Metabolic Diseases; Lipodystrophy; Cardiovascular Disease
Intervention: Combivir (zidovudine [AZT] / lamivudine [3TC]) (Drug); Kaletra (lopinavir [LPVr]) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: The National Centre in HIV Epidemiology and Clinical Research
Official(s) and/or principal investigator(s):
Andrew D Carr, MD FRACP FRCPA, Principal Investigator, Affiliation: National Centre in HIV Epidemiology and Clinical Research
David A Cooper, MD, Study Director, Affiliation: National Centre in HIV Epidemiology and Clinical Research
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
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
Study design: Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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
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.
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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
- Prior use of any retinoid-containing compound within the previous six months.
- 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
- 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
- Evidence of acute or chronic active hepatitis B virus infection by serology performed
- Evidence of hepatitis C infection by serology performed at baseline.
Locations and Contacts
St Vincents Hospital, Sydney, New South Wales 2010, Australia
National Centre in HIV Epidemiology and Clinical Research Homepage
Starting date: November 2004
Ending date: December 2006
Last updated: August 15, 2007