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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:
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
  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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Congenital Abnormalities
Dyslipidemias
Glucose Metabolism Disorders
HIV Infections
Lipodystrophy
Metabolic Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases
Lamivudine, zidovudine drug combination
Lopinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014