HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Further study details as provided by Kirby Institute:

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


Enrollment:	80
Study Start Date:	February 2003
Study Completion Date:	December 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192660

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

Additional Information:

National Centre in HIV Epidemiology and Clinical Research Homepage This link exits the ClinicalTrials.gov site


Responsible Party:	Kirby Institute
ClinicalTrials.gov Identifier:	NCT00192660 History of Changes
Other Study ID Numbers:	HAMA 001 Version 6 R01HL065953-01
Study First Received:	September 12, 2005
Last Updated:	April 11, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

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 Lamivudine Tenofovir Zidovudine Nevirapine Stavudine Didanosine Abacavir Tipranavir Enfuvirtide

ClinicalTrials.gov processed this record on September 27, 2016