HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)

Phase 4

Recruiting

• Conditions: HIV; Metabolic abnormality; Lipodystrophy; Cardiovascular disease; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12605000662662
• Lead Sponsor: The University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to 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

General:- 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 subjects 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 subjects 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 subjects ability to safely complete all study requirements.- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- PregnancySpecific 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in adipocyte structure and function at week 48 in HIV-infected individuals treated with antiretroviral therapy.[At baseline and week 48.]

Secondary Outcome Measures

Name	Time	Method
1. To correlate change in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen.[From baseline to week 48];2. To examine changes in adipocyte function in HIV-infected volunteers both prior to (at baseline) and after 48 weeks 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 (ie cross sectional, single time point comparison) in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump.[]