Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Summary

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.

There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.

The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.

The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

Conditions

• HIV-Associated Lipodystrophy Syndrome

Interventions

DRUG

nucleoside analogue sparing HAART regimen

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Abbott

  collaborator INDUSTRY

• Danish HIV Research Group

  lead OTHER

Principal Investigators

• Jan Gerstoft, M.D., DMSc · Rigshospitalet, Denmark

• Niels Obel, M.D., DMSc · Odense University Hospital

• Court Pedersen, Professor · Odense University Hospital

• Lars Mathiesen, M.D.,DMSc · Hvidovre University Hospital

• Henrik Nielsen, M.D.,DMSc · Aalborg University Hospital

• Alex Laursen, M.D., DMSc · Aarhus University City

• Ann-Brit E Hansen, M.D. · Copenhagen University Hospital Rigshospitalet and Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-06-30

Completion

2007-11-30

Countries

• Denmark

Study Locations