Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
HIV infection is diagnosed late in a substantial proportion of patients having an increased
risk of clinical progression (AIDS, new AIDS-defining event or death). The currently
recommended antiretroviral therapy has suboptimal activity in this setting and potent
quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate
candidate as the fourth antiretroviral agent, regarding its activity, its parenteral
administration avoiding gastrointestinal symptoms that often lead to interruption of
treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.
The aim of this study is to investigate, in a comparative intensification trial, the
immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral
therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral
treatment.
We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting
in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve
immunological restoration, measured as the proportion of patients with more than 200 CD4
cells per mm3 after 24 weeks of antiretroviral therapy.
Phase:
Phase 3
Details
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis