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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter

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.

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.


Detailed Summary:
Sponsor: Danish HIV Research Group

Current Primary Outcome:

  • Changes in peripheral fat mass, determined by DEXA-changes
  • Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
  • Change from baseline in fasting lipids and subsets hereof
  • Development of impaired glucose tolerance and insulin resistance


Original Primary Outcome:

  • Changes in peripheral fat mass, determined by DEXA-Changes Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
  • Change from baseline in fasting lipids and subsets hereof
  • Development of impaired glucose tolerance and insulin resistance


Current Secondary Outcome:

  • 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 randomized 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:

  • 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 randomized 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


Information By: Danish HIV Research Group

Dates:
Date Received: August 25, 2005
Date Started: June 2003
Date Completion: November 2007
Last Updated: March 13, 2006
Last Verified: September 2005