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

St. Luke's-Roosevelt Hospital Center

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: Truvada; Drug: Combivir; Drug: Trizivir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00960622

TRU

Details and patient eligibility

About

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.

Full description

None different from the summary description above.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Truvada

Experimental group

Description:

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

Treatment:

Drug: Truvada

Combivir or Trizivir

Active Comparator group

Description:

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)

Treatment:

Drug: Trizivir

Drug: Combivir