Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to
switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on
Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after
randomization to either continuing on trizivir or combivir, or to switching to Truvada.
Measurements include maximal or peak oxygen consumption, lactate production and clearance,
subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat
contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is
that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors
(NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction
in several organ systems.
Phase:
Phase 4
Details
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborator:
Gilead Sciences
Treatments:
Abacavir Dideoxynucleosides Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine Lamivudine, zidovudine drug combination Tenofovir Zidovudine