Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV	Drug: Truvada Drug: Combivir Drug: Trizivir	Phase 4


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Abacavir Emtricitabine Tenofovir Abacavir sulfate Tenofovir Disoproxil Fumarate Trizivir Truvada

U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

Change in Peak Oxygen Uptake. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.


Enrollment:	17
Study Start Date:	August 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Truvada Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months	Drug: Truvada Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months Other Name: emtricitabine and tenofovir disoproxil fumarate
Active Comparator: Combivir or Trizivir Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months or Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)	Drug: Combivir Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months Other Names: Retrovir zidovudine Epivir lamivudine Drug: Trizivir Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) Other Names: abacavir abacavir sulfate lamivudine zidovudine

Detailed Description:

None different from the summary description above.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960622

Locations


United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Gilead Sciences

Investigators


Principal Investigator:	Donald P Kotler, MD	St Luke's Roosevelt Hospital New York City
Principal Investigator:	Gabriel Ionescu, MD	SLRHC

More Information


Responsible Party:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT00960622 History of Changes
Other Study ID Numbers:	TRU
Study First Received:	August 17, 2009
Results First Received:	September 21, 2011
Last Updated:	January 25, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Luke's-Roosevelt Hospital Center:


treatment experienced

Additional relevant MeSH terms:


Zidovudine Dideoxynucleosides Lamivudine Tenofovir Abacavir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine, zidovudine drug combination Emtricitabine Antimetabolites	Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2016

Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects (TRU)