Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

September 30, 2009

Conditions
HIV Infections
Interventions
DRUG

raltegravir

This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.

Trial Locations (8)

90027

Kaiser Los Angeles, Los Angeles

90034

Kaiser West Los Angeles, Los Angeles

91355

Kaiser Santa Clarita, Santa Clarita

91402

Kaiser Panorama City, Panorama City

92807

Kaiser Anaheim, Anaheim

94118

Kaiser San Francisco, San Francisco

95051

Kaiser Santa Clara, Santa Clara

95454

Kaiser Hayward, Hayward

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Kaiser Permanente

OTHER

NCT00529243 - Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects | Biotech Hunter | Biotech Hunter