HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

NCT ID: NCT00192660

Last Updated: 2012-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-12-31

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.

Conditions

HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Lamivudine

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Tenofovir

Intervention Type: DRUG

Abacavir

Intervention Type: DRUG

Efavirenz (EFV)

Intervention Type: DRUG

Nevirapine

Intervention Type: DRUG

Indinavir

Intervention Type: DRUG

Saquinavir

Intervention Type: DRUG

Amprenavir

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Nelfinavir

Intervention Type: DRUG

Tipranavir

Intervention Type: DRUG

enfuvirtide (T20)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St Vincent's Hospital, Sydney

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew D Carr, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincents Hospital Sydney Limited

David A Cooper, MD

Role: STUDY_DIRECTOR

The National Centre in HIV Epidemiology and Clinical Research, Sydney

Locations

St. Vincent's Hospital

Sydney, New South Wales, Australia

Countries

Australia

Related Links

http://www.med.unsw.edu.au/nchecr/

National Centre in HIV Epidemiology and Clinical Research Homepage

Other Identifiers

R01HL065953-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HAMA 001 Version 6

Identifier Type: -

Identifier Source: org_study_id