drugset / Trial / NCT00781287

Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

NCT00781287

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

Timeline

Start
2009-02
Primary completion
2012-02
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified 400 mg Oral