Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
This study has been completed.
Sponsor:
Kirby Institute
Collaborators:
St Vincent's Hospital, Sydney
Garvan Institute of Medical Research
Prince of Wales Hospital, Sydney
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192621
First received: September 12, 2005
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Kirby Institute:
Primary Outcome Measures:
- 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 Measures:
- 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.
| Enrollment: | 50 |
| Study Start Date: | November 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192621
Locations
| Australia, New South Wales | |
| St Vincents Hospital | |
| Sydney, New South Wales, Australia, 2010 | |
Sponsors and Collaborators
Kirby Institute
St Vincent's Hospital, Sydney
Garvan Institute of Medical Research
Prince of Wales Hospital, Sydney
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT00192621 History of Changes |
| Other Study ID Numbers: | SAMA 002 Version 5, ACTR012605000661673 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Kirby Institute:
|
HIV negative healthy subjects Lipid metabolism Glucose metabolism Metabolic abnormality |
Lipodystrophy Cardiovascular disease Treatment Naive HIV |
Additional relevant MeSH terms:
|
Congenital Abnormalities HIV Infections Acquired Immunodeficiency Syndrome Cardiovascular Diseases Lipodystrophy Metabolic Diseases Dyslipidemias Glucose Metabolism Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Zidovudine Lamivudine Lamivudine, zidovudine drug combination Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013