A Phase 3 interventional study of enfuvirtide and emtricitabine/tenofovir in HIV Infections and AIDS, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 3, Interventional, and Treatment
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.
The purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy:
Patients with lymphocytes T CD4+ cell (CD4)count below 100 per mm3, or CD4 cell count below 200 per mm3 and past history or presence of AIDS defining event and naïve of any antiretroviral therapy will be eligible. This multicenter study will enroll 220 patients (n=110 in each arm). The planned duration of the study is 48 weeks from the enrolment of the last subject.
The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 195 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.
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Exclusion Criteria:
lopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24)
Drug: enfuvirtide · Drug: emtricitabine/tenofovir · Drug: lopinavir or efavirenz
lopinavir or efavirenz and emtricitabine/tenofovir
Drug: emtricitabine/tenofovir · Drug: lopinavir or efavirenz
from week 0 to 24
Also known as: Fuzeon
1 pill/day
Also known as: Truvada
investigator choice
Also known as: Kaletra, Sustiva
Immunological success defined as a CD4 cell count above 200 cells per mm3 after 24 weeks of initial antiretroviral treatment
Time frame: 24 weeks
Virological response, clinical progression, tolerance,toxicity, quality of life under therapy, adherence and resistance mutations emerging in case of virological failure.
Time frame: from 0 to 48 weeks
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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French National Agency for Research on AIDS and Viral Hepatitis