A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy

HIV Infections Clinical Trial

Official title: Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV

Status Completed

Clinical Trial Summary

We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.

Clinical Trial Description

This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.

All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first). ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00344760
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Completion date: March 2007