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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Brief Title

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

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

Brief Summary

      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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


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.

Condition

HIV Infections

Intervention

Combivir (zidovudine [AZT] / lamivudine [3TC])


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

November 2004

Completion Date

December 2006

Primary Completion Date

December 2006

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Andrew D Carr, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00192621

Organization ID

SAMA 002 Version 5

Secondary IDs

ACTR012605000661673

Responsible Party

Sponsor

Study Sponsor

Kirby Institute

Collaborators

 St Vincent's Hospital, Sydney

Study Sponsor

Andrew D Carr, MD, Principal Investigator, National Centre in HIV Epidemiology and Clinical Research.


Verification Date

April 2012