Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

HIV Clinical Trial

— TRU  

Official title:

Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960622
• Other study ID #: TRU
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2009
• Last updated: January 25, 2013
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: September 2012
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

None different from the summary description above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infection with human immunodeficiency virus (HIV) with undetectable viral load

• on Combivir or trizivir

• able to exercise and sign consent

Exclusion Criteria:

• other active illness

• contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Truvada
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
• Combivir
Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
• Trizivir
Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Oxygen Uptake.	change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.	baseline and 6 months	No