HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

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.

Conditions

• HIV-Associated Lipodystrophy Syndrome
• Cardiovascular Disease

Interventions

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)

Sponsors & Collaborators

• St Vincent's Hospital, Sydney

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Kirby Institute

  lead OTHER_GOV

Principal Investigators

• Andrew D Carr, MD · St. Vincents Hospital Sydney Limited

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

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-02-28

Primary Completion

2006-10-31

Completion

2007-12-31

Countries

• Australia

Study Locations