HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00192660
• Date of registration: 12/09/2005
• Primary sponsor: Kirby Institute
• Public title: HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
• Scientific 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
• Date of first enrolment: February 2003
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00192660
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

Australia

Contacts

• Name: Andrew D Carr, MD
• Affiliation: St. Vincents Hospital Sydney Limited

• Name: David A Cooper, MD
• Affiliation: The National Centre in HIV Epidemiology and Clinical Research, Sydney

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Disease

HIV-Associated Lipodystrophy Syndrome

Intervention(s)

Drug: Abacavir

Drug: Amprenavir

Drug: Didanosine

Drug: Efavirenz (EFV)

Drug: enfuvirtide (T20)

Drug: Indinavir

Drug: Lamivudine

Drug: Nelfinavir

Drug: Nevirapine

Drug: Ritonavir

Drug: Saquinavir

Drug: Stavudine

Drug: Tenofovir

Drug: Tipranavir

Drug: Zidovudine

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

HAMA 001 Version 6

RO1 HL65953-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

St Vincent's Hospital, Sydney