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Clinical Trial Details

Seronegatives And Metabolic Abnormalities Protocol 2 (SAMA 002)

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Trial Information

Broad Health Condition Infection
Cardiovascular

Specific Health ConditionAcquired immune deficiency syndrome (AIDS / HIV)
Other cardiovascular diseases

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/11/2004

Anticipated date of last participant enrolment1/11/2004

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial summary

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
Eligibility

Key inclusion criteria

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.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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 subjects 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 subjects 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 (appendix C), which, in the opinion of the investigator, would affect the subjects 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 subjects 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 subjects 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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia

Trial IDACTRN12605000661673

Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research Level 2 376 Victoria Street Darlinghurst NSW 2010
+61 2 83823107

Further information iconpmallon@nchecr.unsw.edu.au
Australia