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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00192660




Registration number
NCT00192660
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
12/04/2012

Titles & IDs
Public title
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
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] 0 0
R01HL065953-01
Secondary ID [2] 0 0
HAMA 001 Version 6
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-Associated Lipodystrophy Syndrome 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lamivudine
Treatment: Drugs - Stavudine
Treatment: Drugs - Didanosine
Treatment: Drugs - Zidovudine
Treatment: Drugs - Tenofovir
Treatment: Drugs - Abacavir
Treatment: Drugs - Efavirenz (EFV)
Treatment: Drugs - Nevirapine
Treatment: Drugs - Indinavir
Treatment: Drugs - Saquinavir
Treatment: Drugs - Amprenavir
Treatment: Drugs - Ritonavir
Treatment: Drugs - Nelfinavir
Treatment: Drugs - Tipranavir
Treatment: Drugs - enfuvirtide (T20)

Treatment: Drugs: Lamivudine


Treatment: Drugs: Stavudine


Treatment: Drugs: Didanosine


Treatment: Drugs: Zidovudine


Treatment: Drugs: Tenofovir


Treatment: Drugs: Abacavir


Treatment: Drugs: Efavirenz (EFV)


Treatment: Drugs: Nevirapine


Treatment: Drugs: Indinavir


Treatment: Drugs: Saquinavir


Treatment: Drugs: Amprenavir


Treatment: Drugs: Ritonavir


Treatment: Drugs: Nelfinavir


Treatment: Drugs: Tipranavir


Treatment: Drugs: enfuvirtide (T20)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Age >18.

- Be able to provide written consent to perform in the trial.

- HIV antibody positive at time of entry to the study.

Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (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
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 subject's 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 subject's 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 subject's ability to safely complete all
study requirements.

- 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

Specific 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
N/A
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
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital, Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00192660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D Carr, MD
Address 0 0
St. Vincents Hospital Sydney Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries