Conditions: HIV Infections
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:

Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400 mg Twice daily for 24 weeks

Protocol document: