Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00192621 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : April 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Lipodystrophy Cardiovascular Disease | Drug: Combivir (zidovudine [AZT] / lamivudine [3TC]) Drug: Kaletra (lopinavir [LPVr]) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
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 Start Date : | November 2004 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |
- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192621
Australia, New South Wales | |
St Vincents Hospital | |
Sydney, New South Wales, Australia, 2010 |
Principal Investigator: | Andrew D Carr, MD | National Centre in HIV Epidemiology and Clinical Research. | |
Study Director: | David A Cooper, MD | National Centre in HIV Epidemiology and Clinical Research. |
Responsible Party: | Kirby Institute |
ClinicalTrials.gov Identifier: | NCT00192621 |
Other Study ID Numbers: |
SAMA 002 Version 5 ACTR012605000661673 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | April 12, 2012 |
Last Verified: | April 2012 |
HIV negative healthy subjects Lipid metabolism Glucose metabolism Metabolic abnormality |
Lipodystrophy Cardiovascular disease Treatment Naive HIV |
Cardiovascular Diseases Congenital Abnormalities Lipodystrophy Dyslipidemias Metabolic Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Skin Diseases, Metabolic Skin Diseases Lamivudine Zidovudine Lamivudine, zidovudine drug combination Lopinavir Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Antimetabolites HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |