NCT00960622

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Aug 2006

Typical duration for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 4, 2013

Completed
Last Updated

March 4, 2013

Status Verified

September 1, 2012

Enrollment Period

2.9 years

First QC Date

August 17, 2009

Results QC Date

September 21, 2011

Last Update Submit

January 25, 2013

Conditions

HIV

Keywords

treatment experienced

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Truvada

EXPERIMENTAL

Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months

Drug: Truvada

Combivir or Trizivir

ACTIVE COMPARATOR

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: CombivirDrug: Trizivir

Interventions

TruvadaDRUG

Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months

Also known as: emtricitabine and tenofovir disoproxil fumarate
Truvada
CombivirDRUG

Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months

Also known as: Retrovir, zidovudine, Epivir, lamivudine
Combivir or Trizivir
TrizivirDRUG

Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)

Also known as: abacavir, abacavir sulfate, lamivudine, zidovudine
Combivir or Trizivir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • infection with human immunodeficiency virus (HIV) with undetectable viral load
  • on Combivir or trizivir
  • able to exercise and sign consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationEmtricitabineTenofovirlamivudine, zidovudine drug combinationZidovudineLamivudineabacavir, lamivudine, and zidovudine drug combinationabacavir

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical PreparationsThymidineDideoxynucleosidesZalcitabine

Results Point of Contact

Title
Dr. Donald Phillip Kotler
Organization
St Luke's Roosevelt Hospital New York
dkotler@chpnet.org
212 523 3670

Study Officials

  • Donald P Kotler, MD

    St Luke's Roosevelt Hospital New York City

    PRINCIPAL INVESTIGATOR

  • Gabriel Ionescu, MD

    SLRHC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 4, 2013

Results First Posted

March 4, 2013

Record last verified: 2012-09

Locations

US(1)