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Clinical Trial Details

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)

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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 enrolment3/02/2004

Anticipated date of last participant enrolment3/02/2004

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial summary

A prospective, non-randomised, 48 week study of the effect of PI containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
Eligibility

Key inclusion criteria

Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to HAMA part A only:- Be naive to antiretroviral medication.Specific to HAMA part B only:- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.- Have had a minimum of 48 weeks interval since completion of HAMA part A.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

General:- 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.-  Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.-  Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.-  Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.-  Prior use of any retinoid-containing compound within the previous six months.- Abnormal coagulation.- Previous allergic reaction or known allergy to local anaesthetic.-  Previous or concomitant use of medications, 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, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements.-  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.-  PregnancySpecific to HAMA part A only:- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors).  Entry of individuals who have had previous antiretroviral therapy as part of Post Exposure Prophylaxis will be at the discretion of the study investigators.
Contact details and further information

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

Trial IDACTRN12605000662662

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