HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease	Drug: Lamivudine; Drug: Stavudine; Drug: Didanosine; Drug: Zidovudine; Drug: Tenofovir; Drug: Abacavir; Drug: Efavirenz (EFV); Drug: Nevirapine; Drug: Indinavir; Drug: Saquinavir; Drug: Amprenavir; Drug: Ritonavir; Drug: Nelfinavir; Drug: Tipranavir; Drug: enfuvirtide (T20)	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
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 Start Date :	February 2003
Actual Primary Completion Date :	October 2006
Actual Study Completion Date :	December 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
2. 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
3. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Kirby Institute

St Vincent's Hospital, Sydney

National Heart, Lung, and Blood Institute (NHLBI)

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kirby Institute
ClinicalTrials.gov Identifier:	NCT00192660 History of Changes
Other Study ID Numbers:	HAMA 001 Version 6; R01HL065953-01 ( U.S. NIH Grant/Contract )
First Posted:	September 19, 2005
Last Update Posted:	April 12, 2012
Last Verified:	April 2012

Keywords provided by Kirby Institute:

HIV; Metabolic abnormality; Lipodystrophy; Cardiovascular disease	Treatment Naive; Treatment Experienced; HIV Infections

Additional relevant MeSH terms:

HIV Infections; Cardiovascular Diseases; Lipodystrophy; HIV-Associated Lipodystrophy Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Lipid Metabolism Disorders	Metabolic Diseases; Ritonavir; Nelfinavir; Indinavir; Saquinavir; Amprenavir; Tenofovir; Lamivudine; Zidovudine; Nevirapine; Abacavir; Stavudine; Didanosine; Tipranavir; Enfuvirtide