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Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

NCT00139178 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2005-09-05

No results posted yet for this study

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.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

Conditions

Interventions

DRUG

Different HAART regimens

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Danish HIV Research Group

    lead OTHER

Principal Investigators

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

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

  • Court Pedersen, Professor · Odense University Hospital

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

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

  • Niels Obel · Odense University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2007-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00139178 on ClinicalTrials.gov