drugset / Trial / NCT00362687

GMB: Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients With Resistance

NCT00362687

Phase 4 Completed 50 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor compliance, poor quality of life, toxicity or development of resistance. In these patients interruption of HAART has a negative impact on patient immune status due to the reemergence of wild-type virus which is in general more pathogenic than HIV isolates containing resistance mutations. There is a need for "bridging" antiretroviral regimens that might prolong time off conventional HAART whilst waiting for a new regimen that is either fully suppressive or less toxic or less demanding for the patient.

Timeline

Start
2006-11
Primary completion
2008-05
Completion
2008-10

Drugs

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