drugset / Trial / NCT00324649

Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

NCT00324649

Phase 4 Completed 80 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2006-05
Primary completion
2008-03
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamivudine Other / unclassified
Subject Tenofovir disoproxil fumarate Small molecule 300 mg
Comparator Zidovudine Small molecule
Subject emtricitabine Other / unclassified 200 mg

Indications

No indication recorded.