The purpose of this study is to: * Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide, * Monitor the safety and efficacy of raltegravir, and * Assess the change in quality of life in patients who have switched from Enfuvirtide to raltegravir
We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir. At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed. Viral load, T-cells, and toxicity were evaluated at baseline, 2, 4, 12 and 24 weeks. Adherence and injection site reactions were evaluated at baseline, 4, 12 and 24 weeks. The single-copy assay was used to measure HIV RNA levels at screening, baseline and at 12 and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
400 mg Twice daily for 24 weeks
Stanford University School of Medicine
Stanford, California, United States
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
evaluate the percent of patients with viral load of \<50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
Time frame: 24 weeks
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