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Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

NCT ID: NCT00960622

Last Updated: 2013-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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None different from the summary description above.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Truvada

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

Group Type EXPERIMENTAL

Truvada

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Combivir

Intervention Type DRUG

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

Trizivir

Intervention Type DRUG

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

Interventions

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Truvada

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

Intervention Type DRUG

Combivir

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

Intervention Type DRUG

Trizivir

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

Intervention Type DRUG

Other Intervention Names

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emtricitabine and tenofovir disoproxil fumarate Retrovir zidovudine Epivir lamivudine abacavir abacavir sulfate lamivudine zidovudine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald P Kotler, MD

Role: PRINCIPAL_INVESTIGATOR

St Luke's Roosevelt Hospital New York City

Gabriel Ionescu, MD

Role: PRINCIPAL_INVESTIGATOR

SLRHC

Locations

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St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TRU

Identifier Type: -

Identifier Source: org_study_id

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