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Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

NCT00324649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-08-17

Study results available
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Summary

This study evaluated changes in body fat distribution in human immunodeficiency virus type 1 (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine- containing highly active antiretroviral therapy (HAART) regimen to a regimen containing Truvada® (a fixed-dose combination tablet of emtricitabine \[FTC, 200 mg\] and tenofovir disoproxil fumarate \[TDF, 300 mg\]) or who remained on a zidovudine- plus lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).

Conditions

Interventions

DRUG

Truvada

Truvada once daily with continuation of the current NNRTI or PI at randomization.

DRUG

Zidovudine/lamivudine

Continuation of the zidovudine + lamivudine containing regimen plus the current NNRTI or PI at randomization.

Sponsors & Collaborators

Principal Investigators

  • Pedro Ferrer · Gilead Sciences, S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324649 on ClinicalTrials.gov