HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

April 11, 2012 updated by: Kirby Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
St Vincent's Hospital, Sydney

Investigators

  • Principal Investigator: Andrew D Carr, MD, St. Vincents Hospital Sydney Limited
  • Study Director: David A Cooper, MD, The National Centre in HIV Epidemiology and Clinical Research, Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAMA 001 Version 6
  • R01HL065953-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Nevirapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe