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