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A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy

LALEZARI, Jacob P ; ERON, Joseph J ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; KILBY, J. Michael ; CARLSON, Margrit ; COHEN, Calvin ; DEJESUS, Edwin ; ARDUINO, Roberto C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L ; VALENTINE, Fred

AIDS (London), 2003-03, Vol.17 (5), p.691-698 [Periódico revisado por pares]

Hagerstown, MD: Lippincott Williams & Wilkins

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Título:
A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy
Autor: LALEZARI, Jacob P ; ERON, Joseph J ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; KILBY, J. Michael ; CARLSON, Margrit ; COHEN, Calvin ; DEJESUS, Edwin ; ARDUINO, Roberto C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L ; VALENTINE, Fred
Assuntos: Adult ; Aged ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - blood ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; CD4 Lymphocyte Count ; Drug Therapy, Combination ; Enfuvirtide ; Female ; HIV Envelope Protein gp41 - adverse effects ; HIV Envelope Protein gp41 - blood ; HIV Envelope Protein gp41 - therapeutic use ; HIV Infections - blood ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - virology ; HIV-1 - isolation & purification ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Peptide Fragments - adverse effects ; Peptide Fragments - blood ; Peptide Fragments - therapeutic use ; Pharmacology. Drug treatments ; RNA, Viral - blood ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids
É parte de: AIDS (London), 2003-03, Vol.17 (5), p.691-698
Descrição: The primary objective was to determine the long-term safety of the subcutaneous self-administration of enfuvirtide. Secondary objectives included the determination of enfuvirtide pharmacokinetics and antiviral activity and the immunological response to the enfuvirtide-containing regimen. A multicenter 48-week uncontrolled open-label rollover study was conducted on 71 HIV-infected adults recruited from previous enfuvirtide clinical trials. Patients with extensive previous use of protease and reverse transcriptase inhibitors received a twice-daily dose of 50 mg enfuvirtide subcutaneously (45 mg deliverable) combined with two or more antiretroviral drugs selected for each individual, guided by resistance testing and previous treatment history. The mean baseline plasma HIV-RNA level was 4.81 log(10) copies/ml and the mean CD4 cell count was 134.8 cells/microl. The majority (86.9%) of treatment-emergent adverse events were grade 2 or less in severity. Injection site reactions were common, but no patients discontinued treatment. A mean HIV-RNA change of -1.33 log(10) was achieved within 14 days of treatment initiation. At week 48, approximately one-third of all patients in the intent-to-treat population maintained significant suppression of plasma HIV RNA, with either less than 400 copies/ml or more than a 1.0 log(10) decline from baseline. The mean gain in absolute CD4 cell counts at 48 weeks was 84.9 cells/microl. Trough plasma concentrations of enfuvirtide were consistently higher than target concentrations. Self-administration of enfuvirtide is not associated with unexpected toxicities for up to one year, and combined with oral antiretroviral drugs was associated with a significant decrease in HIV RNA and an increase in CD4 cell counts.
Editor: Hagerstown, MD: Lippincott Williams & Wilkins
Idioma: Inglês

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A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy

LALEZARI, Jacob P ; ERON, Joseph J ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; KILBY, J. Michael ; CARLSON, Margrit ; COHEN, Calvin ; DEJESUS, Edwin ; ARDUINO, Roberto C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L ; VALENTINE, Fred

Hagerstown, MD: Lippincott Williams & Wilkins

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