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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

Brief 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.


Detailed Summary:
Sponsor: Danish HIV Research Group

Current Primary Outcome: Changes in peripheral fat mass, determined by DEXA-Changes Change from baseline in fasting lipids and subsets hereof. Development of impaired glucose tolerance and insulin resistance.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
  • Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
  • Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
  • Incidence of adverse events.
  • Incidence of clinical disease progression.
  • Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.
  • Change in plasma lactate from baseline.
  • Time to discontinuation of the allocated therapy and reasons for this.
  • Incidence of genotypical and virological resistance. Development of osteopenia, judged by DEXA-scan. Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96.


Original Secondary Outcome: Same as current

Information By: Danish HIV Research Group

Dates:
Date Received: August 30, 2005
Date Started: March 2004
Date Completion: April 2007
Last Updated: September 2, 2005
Last Verified: August 2005