Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000662662
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)
Scientific title
Analysis of Lipodystrophy in HIV-Infected individuals

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.
Secondary ID [1] 197 0
National Heart, Lung, and Blood Institute of the National Institutes of Health: R01 HL65953-01
Universal Trial Number (UTN)
Trial acronym
HAMA 001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV
802 0
Metabolic abnormality 803 0
Lipodystrophy 804 0
Cardiovascular disease 805 0
Condition category
Condition code
Infection 872 872 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 873 873 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 604 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1121 0
Change from baseline in adipocyte structure and function at week 48 in HIV-infected individuals treated with antiretroviral therapy.
Timepoint [1] 1121 0
At baseline and week 48.
Secondary outcome [1] 2073 0
1. To correlate change in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen.
Timepoint [1] 2073 0
From baseline to week 48
Secondary outcome [2] 2074 0
2. To examine changes in adipocyte function in HIV-infected volunteers both prior to (at baseline) and after 48 weeks of treatment in order to determine changes arising directly as a result of therapy.
Timepoint [2] 2074 0
Secondary outcome [3] 2075 0
3. To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD (ie cross sectional, single time point comparison) in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump.
Timepoint [3] 2075 0

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 age
18 Years
Maximum age
Not stated
Sex
Both 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 961 0
Government body
Name [1] 961 0
National Heart Lung and Blood Institute
Country [1] 961 0
United States of America
Funding source category [2] 962 0
Government body
Name [2] 962 0
US National Institutes of Health
Country [2] 962 0
United States of America
Primary sponsor type
University
Name
The University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 830 0
Hospital
Name [1] 830 0
St. Vincents Hospital Sydney Limited
Address [1] 830 0
Country [1] 830 0
Australia
Secondary sponsor category [2] 831 0
Other
Name [2] 831 0
The Garvan Institute of Medical Research
Address [2] 831 0
Country [2] 831 0
Australia
Secondary sponsor category [3] 832 0
Hospital
Name [3] 832 0
Prince of Wales Hospital
Address [3] 832 0
Country [3] 832 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2261 0
St Vincent's Hospital, Sydney Limited
Ethics committee address [1] 2261 0
Ethics committee country [1] 2261 0
Australia
Date submitted for ethics approval [1] 2261 0
Approval date [1] 2261 0
Ethics approval number [1] 2261 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36273 0
Address 36273 0
Country 36273 0
Phone 36273 0
Fax 36273 0
Email 36273 0
Contact person for public queries
Name 9793 0
Patrick WG Mallon
Address 9793 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9793 0
Australia
Phone 9793 0
+61 2 83823107
Fax 9793 0
Email 9793 0
pmallon@nchecr.unsw.edu.au
Contact person for scientific queries
Name 721 0
Andrew D Carr
Address 721 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 721 0
Australia
Phone 721 0
+61 2 83823359
Fax 721 0
Email 721 0
acarr@stvincents.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.