Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: August 15, 2007 History of Changes

Sponsor:	The National Centre in HIV Epidemiology and Clinical Research
Collaborators:	St Vincent's Hospital, Sydney National Heart, Lung, and Blood Institute (NHLBI) Garvan Institute of Medical Research Prince of Wales Hospital, Sydney
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00192621

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 IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety 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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Metabolic Disorders

Drug Information available for: Zidovudine Lamivudine Combivir Lopinavir

U.S. FDA Resources

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

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.

Estimated Enrollment:	50
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2006

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

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

The National Centre in HIV Epidemiology and Clinical Research

St Vincent's Hospital, Sydney

National Heart, Lung, and Blood Institute (NHLBI)

Garvan Institute of Medical Research

Prince of Wales Hospital, Sydney

Investigators

Principal Investigator:	Andrew D Carr, MD FRACP FRCPA	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:

National Centre in HIV Epidemiology and Clinical Research Homepage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SAMA 002 Version 5, ACTR012605000661673
Study First Received:	September 12, 2005
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00192621 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

HIV negative healthy subjects
Lipid metabolism
Glucose metabolism
Metabolic abnormality

Lipodystrophy
Cardiovascular disease
Treatment Naive
HIV

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Retroviral Agents
Lopinavir
Therapeutic Uses
Lipodystrophy
Cardiovascular Diseases
Congenital Abnormalities
Retroviridae Infections
Dyslipidemias
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Metabolic Diseases
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
HIV Infections
Skin Diseases, Metabolic
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009