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HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Primary Purpose

HIV-Associated Lipodystrophy Syndrome, Cardiovascular Disease

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Lamivudine
Stavudine
Didanosine
Zidovudine
Tenofovir
Abacavir
Efavirenz (EFV)
Nevirapine
Indinavir
Saquinavir
Amprenavir
Ritonavir
Nelfinavir
Tipranavir
enfuvirtide (T20)
Sponsored by
Kirby Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV-Associated Lipodystrophy Syndrome focused on measuring HIV, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, Treatment Experienced, HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. 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.

Sites / Locations

  • St. Vincent's Hospital

Outcomes

Primary Outcome Measures

To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy

Secondary Outcome Measures

To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
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
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

Full Information

First Posted
September 12, 2005
Last Updated
April 11, 2012
Sponsor
Kirby Institute
Collaborators
St Vincent's Hospital, Sydney, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00192660
Brief Title
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute
Collaborators
St Vincent's Hospital, Sydney, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-Associated Lipodystrophy Syndrome, Cardiovascular Disease
Keywords
HIV, Metabolic abnormality, Lipodystrophy, Cardiovascular disease, Treatment Naive, Treatment Experienced, HIV Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Intervention Type
Drug
Intervention Name(s)
Abacavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz (EFV)
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Indinavir
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir
Intervention Type
Drug
Intervention Name(s)
Tipranavir
Intervention Type
Drug
Intervention Name(s)
enfuvirtide (T20)
Primary Outcome Measure Information:
Title
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy
Secondary Outcome Measure Information:
Title
To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Carr, MD
Organizational Affiliation
St. Vincents Hospital Sydney Limited
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Cooper, MD
Organizational Affiliation
The National Centre in HIV Epidemiology and Clinical Research, Sydney
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.med.unsw.edu.au/nchecr/
Description
National Centre in HIV Epidemiology and Clinical Research Homepage

Learn more about this trial

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

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