PREventing Progression of Adipose Tissue Redistribution
The main objective of the study is to assess changes in fat distribution over 48 weeks of treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as part of their regimen and who will either continue these antiretrovirals or who will switch these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of these medications is commonly used for the treatment of HIV-1 infection.
Drug: continuing AZT+3TC or switching AZT+3TC to TDF+ FTC
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized, Controlled, Open-Label, 48-Week Study of Continuing Successfully Suppressive Treatment in HIV-1 Infected Adults With First-Line Twice-Daily Zidovudine and Lamivudine-Based Regimens Versus Pro-actively Replacing of Zidovudine and Lamivudine by Once-Daily Emtricitabine and Tenofovir Disoproxil Fumarate to Prevent Progression of or Reverse Peripheral Lipoatrophy.|
- Difference between the continuation arm and the switch arm in:
- changes in subcutaneous and visceral abdominal fat by CT and truncal fat by whole body DEXA over 48 weeks
- changes in lipids (total-, HDL-, and LDL-cholesterol, total /HDL cholesterol ratio, triglycerides), and glucose-metabolism (glucose, insulin) and insulin resistance (HOMA-index1) over 48 weeks.
- incidence of new onset of lipodystrophy and changes in lipodystrophy severity according to the LDCD score.
- changes in bone mineral density by regional DEXA (vertebra L4 and femoral neck) over 48 weeks
- proportion of patients with plasma HIV-1 RNA concentrations < 50 copies/mL after 48 weeks and proportion of patients that developed new CDC-C events or increased in CDC classification.
- incidence and severity of adverse events (grade 3 and 4), and laboratory abnormalities (grade 1-4)
- A comparison between different GFR-estimations and the gold standard for GFR-measurement in HIV-1 infected patients on HAART. [ Time Frame: baseline ] [ Designated as safety issue: No ]Conclusions: Each eGFR estimation underestimated the mGFR. In patients with preserved renal function and suppressed HIV-infection, C&G, 24-hours urine clearance and MDRD-6 based eGFR reasonably estimated true GFR, but cysC-based eGFR did not.
|Study Start Date:||April 2006|
|Study Completion Date:||October 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389194
|Academic Medical Centre|
|Study Chair:||Peter Reiss, MD, PhD||Academic Medical Centre|